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DOUBLE ENDED IMPACTOR
 Request for Information Form |
 Contact Information
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| Company Name | DEPUY SPINE, INC. |
| Address | 325 PARAMOUNT DR. |
| City, State, Zip | RAYNHAM, MA 02767 |
| Country | US |
| FDA Owner/Operator Phone | 508-828-3769 |
| FDA Medical Specialty Code | OR - Orthopedic |
| FDA Product Code | HXG |
| FDA Classification Name | TAMP |
| FDA Device Classification Code | General Controls |
| FDA Regulation Number | 888.4540 |
| FDA Common Generic Name | IMPACTOR |
| FDA Proprietary Device Name | DOUBLE ENDED IMPACTOR |
| FDA Owner / Operator Number | 1526439 |
| FDA Owner / Operator Name | DEPUY SPINE, INC. |
| FDA Establishment Registration Number | 1526439 |
| FDA Registered Establishment Name | DEPUY SPINE, INC. |
| FDA Operation Code(s) |
MS - Specification Developer RR - Repackager/Relabeller |
| FDA Listing Date | 07-09-92 |
| FDA Listing Status Code | Active |
| Differentiation | N/A |
| Keywords | N/A |
| Description | N/A |
| Brochure | N/A |
| Product Website | N/A |
Competitors of DEPUY SPINE, 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 | A.N.A. AMITY IMPEX A.N.A. SQUARE, AIRPORT RD. MURADPUR WEST SIALKOT, PUNJAB, 51360 PK 92-52-4268654 / 92-52-426854 |
A.N.A. AMITY IMPEX | TAMP |
| 2 | ABBOTT SPINE, INC. 12708 RIATA VISTA CIRCLE SUITE B-100 AUSTIN, TX 78727 US 847-937-6100 / 512-533-1038 |
MULTIPLE | TAMP |
| 3 | AESCULAP AG & CO. KG. AM AESCULAP PLATZ TUTTLINGEN, DONAU, D-78532 GM 49-74-6195-1548 / 610-984-9074 |
MULTIPLE | ORTHOPEDIC BONE TAMP |
| 4 | AESCULAP IMPLANT SYSTEMS 3773 CORPORATE PWKY. CENTER VALLEY, PA 18034 US 610-984-9074 / 610-984-9074 |
MULTIPLE | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| 5 | BIOMET, INC. 56 EAST BELL DR. P.O. BOX 587 WARSAW, IN 46581 US 574-267-6639 / 574-372-1742 |
MULTIPLE | VARIOUS TYPES OF ORTHOPEDIC WIRE TAMPS |
| 6 | BUXTON BIOMEDICAL, INC. 15A MELAINE LANE, UNIT 7 EAST HANOVER, NJ 07936 US 913-560-4848 / 973-560-4848 |
NONE | VARIOUS TYPES OF BONE TAMPER |
| 7 | CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES 1430 WAUKEGAN RD. MCGAW PARK, IL 60085 US 847-689-8410 / 847-578-6442 |
MULTIPLE | VARIOUS TYPES AND SIZES OF TAMPS |
| 8 | CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES 5 SUNNEN DR. ST. LOUIS, MO 63143 US 847-689-8410 / 847-578-6442 |
MULTIPLE | VARIOUS TYPES AND SIZES OF TAMPS |
| 9 | DELTA SURGICAL INSTRUMENTS, INC. 95 SCHUNNEMUNK RD. HIGHLAND MILLS, NY 10930 US 845-928-3760 / 845-928-3760 |
MULTIPLE | VARIOUS TYPES OF TAMPS |
| 10 | DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. 11 HAHOSHLIM ST. HERZLIYA, 46724 IS 972-9-9511511 / 972-9-9511511 |
SKY BONE EXPANDER SYSTEM (SKY SYSTEM) | STERILE BONE TAMPS |
| 11 | EXACTECH, INC. 2320 N.W. 66TH CT. GAINESVILLE, FL 32653 US 352-377-1140 / 352-377-1140 150 |
EXACTECH TIBIAL TAMPS | TAMP |
| 12 | GIMMI GMBH CARL-ZEISS-STRASSE 6 TUTTLINGEN, D-78532 GM / 49-746-1965900 |
MULTIPLE | WIRE |
| 13 | HARTMUT OERTEL CHIR. INSTRUMENTE GMBH OBERE VORSTADT 19 TUTTLINGEN, D-78532 GM 746-153-25 / 746-153-25 |
MULTIPLE | VARIOUS |
| 14 | HERMANN MUELLER INH. GEBHARD MUELLER DR. KARL-STORZ-STR. 3 TUTTLINGEN, 78532 GM 49-746-14125 / 49-746-14125 |
TAMP | TAMP |
| 15 | HOLMED CORP. 40 NORFOLK AVE. SOUTH EASTON, MA 02375 US 508-238-3351 / 508-238-3351 |
SAME | SAME |
| 16 | INSTRUMED INTERNATIONAL, INC. 626 COOPER COURT SCHAUMBURG, IL 60173 US 847-908-0292 / 847-908-0292 |
MULTIPLE | USED IN ORTHOPEDIC PROCEDURES |
| 17 | K2M, INC. 751 MILLER DR.,S.E., SUITE F1 LEESBURG, VA 20175 US 703-777-3155 / 703-777-3155 |
TAMP | TAMP |
| 18 | KLS-MARTIN L.P. 11239-1 ST. JOHN'S IND. PKWY. SOUTH JACKSONVILLE, FL 32246 US 011-497-463838110 / 800-625-1557 |
MULTIPLE | VARIOUS TYPES OF INSTRUMENTS |
| 19 | KYPHON, INC. 1221 CROSSMAN AVE. SUNNYVALE, CA 94089 US 408-548-6500 / 408-548-6660 |
KYPHX INFLATABLE BONE TAMP | VARIOUS TYPES OF STERILE, INFLATABLE BONE TAMPS |
| 20 | LIFE INSTRUMENT CORP. 14 WOOD RD. BRAINTREE, MA 02184 US 781-849-0109 / 781-849-0109 |
TAMP | TAMP |
| 21 | MEDICAL EQUIPMENT & DEVICES, INC. 65 WINTER STREET WEYMOUTH, MA 02188 US 781-337-3070 / 781-337-3070 |
TAMP | TAMP |
| 22 | MEDICON, E.G. GAENSAECKER 15 TUTTLINGEN, D-78532 GM 49-746-220090 / 49-746-220090 |
TAMP | TAMP |
| 23 | MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING 2975 BROTHER BLVD. BARTLETT, TN 38133 US 763-514-4000 / 901-396-3133 4668 |
MULTIPLE | MULTPLE TAMPS |
| 24 | MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE MEMPHIS, TN 38132 US 763-514-4000 / 901-344-1538 |
MULTIPLE | MULTPLE TAMPS |
| 25 | MEDTRONIC SOFAMOR DANEK USA, INC. 4340 SWINNEA RD. MEMPHIS, TN 38118 US 763-514-4000 / 901-396-3133 4668 |
MULTIPLE | MULTPLE TAMPS |
| 26 | MILTEX, INC. 589 DAVIES DRIVE YORK, PA 17402 US 609-275-0500 / 717-840-3409 |
MILTEX | BONE TAMP, VARIOUS MODELS |
| 27 | MINSURG CORPORATION 2730 MCMULLEN BOOTH RD. SUITE 203 CLEARWATER, FL 33761 US 727-466-4550 / 727-475-5194 |
IMPACTER | TAMP |
| 28 | OTTO LEIBINGER GMBH 27 GRIESWEG MUHLHEIM, 78570 GM 49-746-37232 / 49-746-37232 |
TAMP (MULTIPLE BRANDS) | BONE TAMP |
| 29 | PFAU MEDIZINISCHE INSTRUMENTE GMBH DROSSELWEG 7 WANFRIED, 37281 GM 49-565-5704 / 49-565-5704 |
KINE-BOHNE-TAMP | TAMP |
| 30 | SKYTEX CORPORATION WAZIRABAD ROAD, P.O.BOX. 490 SIALKOT, PUNJAB, PK 92-52-4262048 / 92-52-4262048 |
TAMP | TAMP |
| 31 | SMITH & NEPHEW INC., ENDOSCOPY DIV. 130 FORBES BLVD. MANSFIELD, MA 02048 US 978-749-1000 / 978-749-1073 |
MULTIPLE | VARIOUS TAMPS |
| 32 | SPINE SURGICAL INNOVATION 40 NORFOLK AVENUE SOUTH EASTON, MA 02375 US 508-238-3351 / 508-238-3351 |
TAMP | TAMP |
| 33 | SPINE WAVE, INC. TWO ENTERPRISE DR. SUITE 302 SHELTON, CT 06484 US 203-944-9494 340 / 203-944-9494 340 |
TAMP | VARIOUS TYPES OF TAMPS |
| 34 | STORK INSTRUMENTE GMBH ENGENERSTR. 29 EMMINGEN-LIPTINGEN 1, 78576 GM 074-65-825 / 49-74-65 2216 |
MULTIPLE | VARIOUS |
| 35 | SYMMETRY MEDICAL USA, INC. 486 WEST 350 NORTH WARSAW, IN 46582 US 207-786-2775 / 574-371-2213 2213 |
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | BONE TAMP |
| 36 | SYNTHES (USA) 1051-1101 SYNTHES AVE. MONUMENT, CO 80132 US 610-719-5000 / 484-356-9728 |
MULTIPLE | VARIOUS TYPES AND SIZES OF WIRE TIGHTNERS/TAMPS |
| 37 | SYNTHES (USA) 1301-1303 GOSHEN PKWY. WEST CHESTER, PA 19380 US 610-719-5000 / 484-356-9728 |
MULTIPLE | VARIOUS TYPES AND SIZES OF BONE TAMPS |
| 38 | SYNTHES BETTLACH GMBH MURACHERSTRASSE 3 BETTLACH, SO, 2544 SZ 41-32-6441644 / 41-61-965 62 22 |
WIRE TIGHTENER | WIRE TIGHTENER |
| 39 | TELEFLEX MEDICAL 2917 WECK DR. RESEARCH TRIANGLE PARK, NC 27709 US 919-544-8000 / 919-433-4829 |
MULTIPLE ORTHOPEDIC TAMPS | VARIOUS TYPES OF ORTHOPEDIC TAMPS |
| 40 | TELEFLEX MEDICAL TUTTLINGEN GMBH GAENSAECKER 36 TUTTLINGEN, 78532 GM 919-544-8000 / 919-433-4829 |
MULTIPLE TAMPS | VARIOUS TYPES OF TAMPS |
| 41 | WALDEMAR LINK GMBH & CO. KG BARKHAUSENWEG 10 HAMBURG, 22339 GM / 40-539-95-0 *240 |
WIRE TAMP | WIRE TAMP |
| 42 | WARSAW ORTHOPEDIC, INC. 2500 SILVEUS CROSSING WARSAW, IN 46582 US 763-514-4000 / 901-396-3133 4668 |
MULTIPLE | MULTPLE TAMPS |
| 43 | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. ARLINGTON, TN 38002 US 901-867-4732 / 901-867-9971 |
MULTIPLE | VARIOUS TYPES OF WIRE TAMPES |
| 44 | ZIMMER SPINE, INC. 7375 BUSH LAKE RD. MINNEAPOLIS, MN 55439 US 800-613-6131 / 952-830-6273 |
SOFT GRAFT TAMP | TAMP |
| 45 | ZIMMER TRABECULAR METAL TECHNOLOGY 10 POMEROY RD. PARSIPPANY, NJ 07054 US 800-613-6131 / 201-818-1800 |
ACETABULAR, RESTRICTOR TRIAL-TAMP | ACETABULAR, RESTRICTOR TRIAL-TAMP |
| 46 | ZIMMER, INC. 345 E. MAIN ST. WARSAW, IN 46580 US 800-613-6131 / 574-372-4485 |
MULTIPLE | MULTIPLE |
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