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TAP
 Request for Information Form |
 Contact Information
|
| Company Name | SPINE WAVE, INC. |
| Address | TWO ENTERPRISE DR.
SUITE 302 |
| City, State, Zip | SHELTON, CT 06484 |
| Country | US |
| FDA Owner/Operator Phone | 203-944-9494 340 |
| FDA Medical Specialty Code | OR - Orthopedic |
| FDA Product Code | HWX |
| FDA Classification Name | TAP, BONE |
| FDA Device Classification Code | General Controls |
| FDA Regulation Number | 888.4540 |
| FDA Common Generic Name | TAP |
| FDA Proprietary Device Name | TAP |
| FDA Owner / Operator Number | 9055730 |
| FDA Owner / Operator Name | SPINE WAVE, INC. |
| FDA Establishment Registration Number | 3004638600 |
| FDA Registered Establishment Name | SPINE WAVE, INC. |
| FDA Operation Code(s) |
MM - Manufacturer MS - Specification Developer |
| FDA Listing Date | 06-14-07 |
| FDA Listing Status Code | Active |
| Differentiation | N/A |
| Keywords | N/A |
| Description | N/A |
| Brochure | N/A |
| Product Website | N/A |
Competitors of SPINE WAVE, INC.
Our records indicate that the following medical device companies may manufacture a similar device.| Company Name / Address / Phone | Proprietary Device Name | Common Generic Device Name | |
| 1 | 3DIMENSIONAL ENGINEERING, INC. 2991 N. POWERLINE ROAD POMPANO BEACH, FL 33069 US 954-972-9906 / 813-645-2855 |
SCIENT'X BONE TAPS | BONE TAP |
| 2 | AAP IMPLANTATE AG LORENZWEG 5 BERLIN, 12099 GM 49- 30-75019 192 / 49-30-75019x192 |
MULTIPLE-AAP TAP, APS TAP | VARIOUS TYPES OF BONE TAPS |
| 3 | ABBOTT SPINE, INC. 12708 RIATA VISTA CIRCLE SUITE B-100 AUSTIN, TX 78727 US 847-937-6100 / 512-533-1038 |
MULTIPLE | TAP |
| 4 | AESCULAP AG & CO. KG. AM AESCULAP PLATZ TUTTLINGEN, DONAU, D-78532 GM 49-74-6195-1548 / 610-984-9074 |
BONE TAP | VARIOUS MODELS |
| 5 | AESCULAP IMPLANT SYSTEMS 3773 CORPORATE PWKY. CENTER VALLEY, PA 18034 US 610-984-9074 / 610-984-9074 |
BONE TAP | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| 6 | ASCENT HEALTHCARE SOLUTIONS 10232 SOUTH 51ST ST. PHOENIX, AZ 85044 US 480-763-5300 / 480-763-5350 |
MULTIPLE | TAP |
| 7 | AUGUST REUCHLEN GMBH JUNKERSSTRASSE 8 TUTTLINGEN, D-78532 GM 497-461-96520 / 497-461-96520 |
MULTIPLE | VARIOUS TYPES OF TAP, BONE SCREW |
| 8 | BIOCOMPOSITES LTD. KEELE SCIENCE PARK KEELE, STAFFORDSHIRE, ST5 5NL UK 44-178-2338580 / 44-178-2338580 |
BILOK TAP | ACL BONE TAP |
| 9 | BIOMET MICROFIXATION, INC. 1520 TRADEPORT DR. JACKSONVILLE, FL 32218 US 800-874-7711 / 904-741-9258 |
MULTIPLE | TAP, BONE |
| 10 | BIOMET, INC. 56 EAST BELL DR. P.O. BOX 587 WARSAW, IN 46581 US 574-267-6639 / 574-372-1742 |
MULTIPLE | VARIOUS TYPES OF BONE SCREW TAPS |
| 11 | BIOPLATE, INC. 3643 LENAWEE AVE. LOS ANGELES, CA 90016 US 310-815-2100 / 310-815-2100 |
TAP, BONE | TAP, BONE |
| 12 | BLACKSTONE MEDICAL, INC. 1211 HAMBURG TURNPIKE SUITE 300 WAYNE, NJ 07470 US 413-731-8711 / 973-406-2838 |
CANNULATED TAP | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| 13 | BLACKSTONE MEDICAL, INC. 90 BROOKDALE DR. SPRINGFIELD, MA 01104 US 413-731-8711 / 973-406-2838 |
CANUULATED TAP | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| 14 | CM INSTRUMENTE GMBH GANSACKER 56 TUTTLINGEN, BW, DE, 78532 GM 49-074-622042061 / 49-074-622042061 |
CM BONE TAP | BONE TAP |
| 15 | CODMAN & SHURTLEFF, INC. 325 PARAMOUNT DR. RAYNHAM, MA 02767 US 508-828-3704 / 508-828-3704 |
MULTIPLE | BONE TAPS |
| 16 | CODMAN AND SHURTLEFF, INC. 50 SCOTLAND PARK DRIVE BRIDGEWATER, MA 02324 US 508-828-3704 / 508-828-3704 |
MULTIPLE | BONE TAPS |
| 17 | CONMED LINVATEC BIOMATERIALS P.O. BOX 3 HERMIANKATU 6-8L TAMPERE, FIN-33720 FI 727-399-5234 / 727-399-5334 |
SMARTSCREW,BIOSORB,BIOCUFF,DUET | TAP, BONE |
| 18 | CUSTOM SPINE, INC. 1140 PARSIPPANY BLVD. SUITE 201 PARSIPPANY, NJ 07054 US 973-808-0019 / 973-808-0019 |
ISSYS TAPS (4.5, 5.5, 6.5, & 7.5MM) | TAPS, BONE |
| 19 | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 50 SCOTLAND BLVD. BRIDGEWATER, MA 02324 US 508-977-3804 / 508-977-3804 |
MULTIPLE | VARIOUS BONE TAPS |
| 20 | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. RAYNHAM, MA 02767 US 508-977-3804 / 503-977-3804 |
MULTIPLE | VARIOUS BONE TAPS |
| 21 | DEPUY SPINE, INC. 325 PARAMOUNT DR. RAYNHAM, MA 02767 US 508-828-3769 / 508-828-3769 |
VSP BONE TAP | BONE TAP |
| 22 | DIMEDA INSTRUMENTE GMBH GANSACKER 58 TUTTLINGEN, D-78502 GM 49-74-62-9461-0 / 49-74-62-9461-0 |
MULTIPLE | VARIOUS MODELS OF TAPS,BONE |
| 23 | GENERAL SURGICAL CO., (INDIA) PVT. LTD. G-6, GEE GEE CRESCENT 114, POONAMALLEE HIGH ROAD CHENNAI, TAMIL NADU, 600 084 IN 91-44-28233280 / 91-44-28233280 |
TAP, BONE | BONE TAP ALL SIZES |
| 24 | GRACE ENGINEERING CORP. 34775 POTTER ST. MEMPHIS, MI 48041 US 810-392-2181 / 810-392-2181 142 |
BIOMET | BONE TAP |
| 25 | HEBUMEDICAL GMBH BADSTRASSE 8 TUTTLINGEN, 78532 GM 011-746-1 94710 / 011-746-194710 |
MULTIPLE | VARIOUS |
| 26 | HOLMED CORP. 40 NORFOLK AVE. SOUTH EASTON, MA 02375 US 508-238-3351 / 508-238-3351 |
SAME | SAME |
| 27 | INTERVENTIONAL SPINE, INC. 13700 ALTON PKWY., SUITE 160 IRVINE, CA 92618 US 949-472-0006 / 949-472-0006 |
HP TAP, 7.3MM | TAP |
| 28 | K2M, INC. 751 MILLER DR.,S.E., SUITE F1 LEESBURG, VA 20175 US 703-777-3155 / 703-777-3155 |
TAP | TAP |
| 29 | KLS-MARTIN L.P. 11239-1 ST. JOHN'S IND. PKWY. SOUTH JACKSONVILLE, FL 32246 US 011-497-463838110 / 800-625-1557 |
MULTIPLE | MULTIPLE |
| 30 | LENOX-MACLAREN SURGICAL CORP. 657 SOUTH TAYLOR AVE., #A LOUISVILLE, CO 80027 US 720-890-9660 / 720-890-9660 |
TAP, BONE | TAP, BONE |
| 31 | LINVATEC CORP. 11311 CONCEPT BLVD. LARGO, FL 33773 US 727-399-5234 / 727-399-5334 |
STANDARD INTERFERENCE SCREW TAP | BONE TAP,VARIOUS SIZES |
| 32 | MAHE MEDICAL GMBH FRIEDRICH-WOEHLER-STR. 10 EMMINGEN-LIPTINGEN, 78576 GM 49-746-5 9275 0 / 49-746-5 92750 |
MULTIPLE | TAP |
| 33 | MATTES-INSTRUMENTE 27 HALDENSTRASSE TUTTLINGEN, BW, 78532 GM 49-746-13643 / 49-746-13643 |
MATTES BONE TAP | BONE TAP |
| 34 | MEDISISS 2747 SW 6TH STREET REDMOND, OR 97756 US 541-923-3310 / 541-923-3310 |
MULTIPLE | VARIOUS BONE TAPS,STERILE |
| 35 | MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE MEMPHIS, TN 38132 US 763-514-4000 / 901-344-1538 |
TAP, BONE SCREW | |
| 36 | MILTEX, INC. 589 DAVIES DRIVE YORK, PA 17402 US 609-275-0500 / 717-840-3409 |
BONE TAP | BONE TAP |
| 37 | NEWDEAL S.A. 10, PLACE D'HELVETIE LYON, 69006 FR 609-275-0500 / 609-936-2311 |
TAP, BONE (MULTIPLE BRANDS) | TAP |
| 38 | OSTEOMED L.P. 3885 ARAPAHO RD. ADDISON, TX 75001 US 972-677-4600 / 972-677-4787 |
MULTIPLE | VARIOUS TYPES AND SIZES OF BONE TAPS |
| 39 | OTTO LEIBINGER GMBH 27 GRIESWEG MUHLHEIM, 78570 GM 49-746-37232 / 49-746-37232 |
TAP, BONE (MULTIPLE BRANDS) | TAP SLEEVE |
| 40 | PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE MARQUETTE, MI 49855 US 906-226-4812 / 906-226-9909 |
MULTIPLE | TAP |
| 41 | PRECIMED SA. L' ECHELETTE 7 ORVIN, 2534 SZ 011-41-32-3580111 / 260-244-6300 204 |
BONE TAP | BONE TAP |
| 42 | REGENERATION TECHNOLOGIES, INC. 11621 RESEARCH CIR. P.O. BOX 2650 ALACHUA, FL 32616 US 386-418-8888 / 386-418-8888 4382 |
STERLING INTERFERENCE SCREW ST TAP | HT TAP, ST TAP |
| 43 | SCIENT'X 5 RUE ALFRED KASTLER, CALYPSO BLDG.,3 PARC ARIANE GUYANCOURT, 78284 FR 330-139-306930 / 407-571-2550 |
MULTIPLE | VARIOUS BONE TAPS |
| 44 | SCIENT'X USA, INC. 1015 MAITLAND CENTER COMMONS SUITE 106A MAITLAND, FL 32751 US 330-139-306930 / 407-571-2550 |
MULTIPLE | VARIOUS BONE TAPS |
| 45 | SKYTEX CORPORATION WAZIRABAD ROAD, P.O.BOX. 490 SIALKOT, PUNJAB, PK 92-52-4262048 / 92-52-4262048 |
TAP, BONE | TAP, BONE |
| 46 | SMITH & NEPHEW INC., ENDOSCOPY DIV. 130 FORBES BLVD. MANSFIELD, MA 02048 US 978-749-1000 / 978-749-1073 |
MULTIPLE | VARIOUS BONE TAPS |
| 47 | SONTEC INSTRUMENTS, INC. 7248 SOUTH TUCSON WAY CENTENNIAL, CO 80112 US 303-790-9411 / 303-790-9411 |
||
| 48 | SPINE SURGICAL INNOVATION 40 NORFOLK AVENUE SOUTH EASTON, MA 02375 US 508-238-3351 / 508-238-3351 |
BONE TAP | BONE TAP |
| 49 | SPINEVISION, S.A. 180 AVENUE DAUMESNIL PARIS, F-75012 FR 330-533-325251 / 415-512-2500 |
TAP, BONE (MULTIPLE BRANDS) | VARIOUS TYPES OF BONE TAP |
| 50 | STERILMED, INC. 11400 73RD AVE. NORTH, #100 MAPLE GROVE, MN 55369 US 763-488-3400 / 763-488-3410 |
TAP | BONE TAP |
| 51 | STRYKER ENDOSCOPY 5900 OPTICAL CT. SAN JOSE, CA 95138 US 269-385-2600 / 408-754-2124 |
STRYKER COMBO PUNCH/TAP | BONE TAP |
| 52 | STRYKER LEIBINGER GMBH & CO. KG BOTZINGER STRASSE 41 FREIBURG, D-79111 GM 269-385-2600 / 49-761-4512x185 |
MULTIPLE | TAP |
| 53 | STUCKENBROCK MEDIZINTECHNIK GMBH LESSINGSTRASSE 50 TUTTLINGEN, 78532 GM 074-61-161114 / 074-611-61114 |
MULTIPLE | VARIOUS MODELS OF BONE TAPS |
| 54 | SURETEK MEDICAL 25-B MAPLE CREEK CIRCLE GREENVILLE, SC 29607 US 864-299-9743 / 864-299-9743 |
TAP, BONE | REPROCESSED BONE TAP |
| 55 | SYNTHES (USA) 35 AIRPORT RD. HORSEHEADS, NY 14845 US 610-719-5000 / 484-356-9728 |
MULTIPLE | VARIOUS TYPES AND SIZES OF BONE TAPS |
| 56 | SYNTHES (USA) 1301-1303 GOSHEN PKWY. WEST CHESTER, PA 19380 US 610-719-5000 / 484-356-9728 |
MULTIPLE | VARIOUS |
| 57 | SYNTHES (USA) 1051-1101 SYNTHES AVE. MONUMENT, CO 80132 US 610-719-5000 / 484-356-9728 |
MULTIPLE | VARIOUS TYPES AND SIZES OF BONE TAPS |
| 58 | SYNTHES BETTLACH GMBH MURACHERSTRASSE 3 BETTLACH, SO, 2544 SZ 41-32-6441644 / 41-61-965 62 22 |
MULTIPLE | VARIOUS |
| 59 | SYNTHES GMBH EIMATTSTRASSE 3 OBERDORF, CH-4436 SZ 41-32-6441644 / 41-61-965 62 22 |
MULTIPLE | VARIOUS |
| 60 | SYNTHES HAGENDORF GMBH IM BIFANG HAGENDORF, CH-4614 SZ 41-32-6441644 / 41-61-965 62 22 |
MULTIPLE | VARIOUS TYPES AND SIZES OF TAPS |
| 61 | SYNTHES TUTTLINGEN UNTER HASSLEN 5 TUTTLINGEN, 78532 GM / 484-356-9728 |
BONE TAP | BONE TAPS |
| 62 | TAE YEON MEDICAL CO LTD 204,NAMDONG INDUSTRIAL COMPLEX 45B-6L, #435-6, NONHYUN-DONG, INCHEON, NAMDONG-GU, 405-848 KS 82-32-2357375 / 770-565-6166 |
SCREW TAPPER | BONE TAP |
| 63 | TELEFLEX MEDICAL 2917 WECK DR. RESEARCH TRIANGLE PARK, NC 27709 US 919-544-8000 / 919-433-4829 |
MULTIPLE ORTHOPEDIC BONE TAPS | VARIOUS TYPES OF ORTHOPEDIC BONE TAPS |
| 64 | TELEFLEX MEDICAL TUTTLINGEN GMBH GAENSAECKER 36 TUTTLINGEN, 78532 GM 919-544-8000 / 919-433-4829 |
MULTIPLE BONE TAPS | VARIOUS TYPES OF TAPS |
| 65 | U&I CORP. 529-1 YONGHYUN-DONG EUIJUNGBU, KYUNGGI-DO, 480-050 KS 011-823-18520102 / 952-746-8074 |
TAP-4.OMM, TAP-5.OMM, TAP-6.OMM, TAP-7.0MM, TAP-7.5MM, TAP-8.0MM | BONE TAP |
| 66 | UDO SCHILLING CNC-DREHTEILE JOSEF-LANG-STR. 30 A MUHLHEIM-STETTEN, D-78570 GM 074-63-242 / 074-63-242 |
TAP, BONE | TAP, BONE |
| 67 | ULRICH GMBH & CO. KG BUCHBRUNNENWEG 12 ULM, D-89081 GM 07-31-9654-0 / 004-973-19654x163 |
ULRICH BONE TAP | BONE TAP |
| 68 | WARSAW ORTHOPEDIC, INC. 2500 SILVEUS CROSSING WARSAW, IN 46582 US 763-514-4000 / 901-396-3133 4668 |
BONE TAP | BONE TAP |
| 69 | WEBER INSTRUMENTE GMBH FRIEDRICH-WOHLER-STRASSE 8 EMMINGEN-LIPTINGEN, 78576 GM 049-74-65-920900 / 049-746-59209011 |
MULTIPLE | TAP |
| 70 | ZEPF MEDICAL INSTRUMENTS GMBH 21 GUNNINGER ST. SEITINGEN-OBERFLACHT, D-78606 GM 49-746-4 985060 / 497-464-9850625 |
TAP, BONE | TAP, BONE |
| 71 | ZIMMER GMBH SULZER ALLEE 8 WINTERTHUR, CH-8404 SZ / 574-372-4485 |
MULTIPLE | VARIOUS TYPES ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| 72 | ZIMMER SPINE, INC. 7375 BUSH LAKE RD. MINNEAPOLIS, MN 55439 US 800-613-6131 / 952-830-6273 |
MULTIPLE | BONE TAP |
| 73 | ZIMMER, INC. 345 E. MAIN ST. WARSAW, IN 46580 US 800-613-6131 / 574-372-4485 |
MULTIPLE | VARIOUS SIZES OF BONE SCREW TAPS |
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