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OSTEOTOME
 Request for Information Form |
 Contact Information
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| 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 | SU - General Plastic Surgery |
| FDA Product Code | GFI |
| FDA Classification Name | OSTEOTOME, MANUAL |
| FDA Device Classification Code | General Controls |
| FDA Regulation Number | 878.4800 |
| FDA Common Generic Name | OSTEOTOME |
| FDA Proprietary Device Name | OSTEOTOME |
| 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) |
MS - Specification Developer |
| FDA Listing Date | 06-30-06 |
| 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 | A.HANDTE MEDIZINTECHNIK GMBH & CO. KG EHRENBERGSTRASSE 39 TUTTLINGEN, D-78532 GM 074-61-15337 / 074-61-15337 |
MULTIPLE | VARIOUS MODELS OF MANUAL OSTEOTOMES |
| 2 | ABBOTT SPINE, INC. 12708 RIATA VISTA CIRCLE SUITE B-100 AUSTIN, TX 78727 US 847-937-6100 / 512-533-1038 |
MULTIPLE | OSTEOTOME |
| 3 | AESCULAP IMPLANT SYSTEMS 3773 CORPORATE PWKY. CENTER VALLEY, PA 18034 US 610-984-9074 / 610-984-9074 |
OSTEOTOME, MANUAL | MANUAL SURGICAL INSTRUMENT FOR GENERAL USE |
| 4 | AESCULAP, INC. 3773 CORPORATE PKWY. CENTER VALLEY, PA 18034 US 800-258-1946 / 610-984-9074 |
VARIOUS | VARIOUS |
| 5 | BAUSCH & LOMB, INC. 499 SOVEREIGN CT. MANCHESTER, MO 63011 US 585-338-6000 / 585-338-8731 |
MULTIPLE | VARIOUS TYPES OF MANUAL OSTEOTOMES |
| 6 | BEZNOSKA S.R.O. 2727 DELNICKA KLADNO 2, 27201 EZ 420-312-661677 / 44-208-4240790 |
OSTEOTOME, MANUAL (MULTIPLE BRANDS) | OSTEOTOME |
| 7 | BONTEMPI MEDIZINTECHNIK GMBH BODENSEESTR. 1 TUTTLINGEN, D-78532 GM 49-746-1966750 / 497-461-966752 |
MULTIPLE | VARIOUS TYPES OF MANUAL OSTEOTOMES |
| 8 | CARDINAL HEALTH GERMANY 206 GMBH KANTSTRASSE 33/1 TUTTLINGEN, D-78573 GM 847-689-8410 / 847-578-6442 |
MULTIPLE | MANUAL SURGICAL INSTRUMENT FOR GENERAL USE |
| 9 | CARDINAL HEALTH, SNOWDEN PENCER PRODUCTS 5175 SOUTH ROYAL ATLANTA DR. TUCKER, GA 30084 US 847-689-8410 / 847-578-6442 |
MULTIPLE | VARIOUS STYLES OF MANUAL OSTEOTOMES |
| 10 | CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES 1240 WAUKEGAN RD. MCGAW PARK, IL 60085 US 847-689-8410 / 847-578-6442 |
MULTIPLE | VARIOUS STYLES OF MANUAL OSTEOTOMES |
| 11 | CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES 5 SUNNEN DR. ST. LOUIS, MO 63143 US 847-689-8410 / 847-578-6442 |
MULTIPLE | VARIOUS STYLES OF MANUAL OSTEOTOMES |
| 12 | CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES 1430 WAUKEGAN RD. MCGAW PARK, IL 60085 US 847-689-8410 / 847-578-6442 |
MULTIPLE | VARIOUS STYLES OF MANUAL OSTEOTOMES |
| 13 | CHM 16-061 LEWICKIE 3B K/BIALEGOSLCKU, PL |
OSTEOTOME, MANUAL | OSTEOTOME, MANUAL / VARIOUS SIZES |
| 14 | COMBINED INSTRUMENTS (PVT.), LTD. 13-A MODEL TOWN, UGOKI SAILKOT, PK 04-32-510243 / 05-24-510243 |
OSTEOTOME, MANUAL | SAME |
| 15 | DEPUY SPINE, INC. 325 PARAMOUNT DR. RAYNHAM, MA 02767 US 508-828-3769 / 508-828-3769 |
WALLIE-HEINIG OSTEOTOMES | OSTEOTOME |
| 16 | DIMEDA INSTRUMENTE GMBH GANSACKER 58 TUTTLINGEN, D-78502 GM 49-74-62-9461-0 / 49-74-62-9461-0 |
MULTIPLE | VARIOUS MODELS OF OSTEOTOMES, MANUAL |
| 17 | DYNAMIC SURGICAL (PVT) LTD WAZIRABAD RD UGOKI SIALKOT, PK 92-52-3510268 / 92-52-3510268 |
OSTEOTOME MANUAL | OSTEOTOME MANUAL |
| 18 | FALCON SURGICAL CO (PVT) LTD. WAZIRABAD RD., P.O. BOX 134 NEAR VILLAGE GOLOPHALA UGOKI SIALKOT, PK 092-523-510072 / 720-962-5412 |
MULTIPLE | VARIOUS MODELS OF OSTEOTOME, MANUAL |
| 19 | FALCON SURGICAL CO (PVT) LTD. KHADIM ALI RD. P.O. BOX 134 SIALKOT, PUNJAB, 51310 PK 092-523-510072 / 043-2-553428 |
MULTIPLE | VARIOUS MODELS OF OSTEOTOME, MANUAL |
| 20 | 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 |
OSTEOTOME | OSTEOTOME-STRAIGHT OR CURVED-ALL SIZES |
| 21 | GEORGE TIEMANN & CO. 25 PLANT AVE. HAUPPAUGE, NY 11788 US 631-273-0005 / 631-273-0005 |
OSTEOTOME, MANUAL | |
| 22 | H & H CO. 4435 EAST AIRPORT DR., #108 ONTARIO, CA 91761 US 909-390-0373 / 909-390-0373 |
RIDGE EXPANSION OSTEOTOME | RIDGE EXPANSION OSTEOTOME, ALL TYPES |
| 23 | HOLMED CORP. 40 NORFOLK AVE. SOUTH EASTON, MA 02375 US 508-238-3351 / 508-238-3351 |
SAME | SAME |
| 24 | HU-FRIEDY MFG. CO.,INC. 3232 NORTH ROCKWELL ST. CHICAGO, IL 60618 US 773-975-6100 / 773-975-6100 |
MULTIPLE | VARIOUS |
| 25 | INSTRUMED GMBH 31 DORNIERSTRASSE TUTTLINGEN, 78532 GM 49-746-1161133 / 49-746-1161133 |
MULTIPLE | VARIOUS |
| 26 | INSTRUMED INTERNATIONAL, INC. 626 COOPER COURT SCHAUMBURG, IL 60173 US 847-908-0292 / 847-908-0292 |
MULTIPLE | USED IN GENERAL SURGERY |
| 27 | LENOX-MACLAREN SURGICAL CORP. 657 SOUTH TAYLOR AVE., #A LOUISVILLE, CO 80027 US 720-890-9660 / 720-890-9660 |
OSTEOTOME, MANUAL | OSTEOTOME, MANUAL / ALL SIZES |
| 28 | LIFECARE SURGICAL INSTRUMENTS CARNAVAL INDUSTRIAL COMPOUND 3RD INDUSTRIAL ZONE 6TH OF OCTOBER CITY, GIZA, EG 20-2-672314 / 20-2-6720314 |
LIFECARE SURGICAL INSTRUMENTS (MULTIPLE) | MANUAL GENERAL & PLASTIC SURGERY SURGICAL INSTRUMENTS(MANUAL OSTEOTOME) |
| 29 | MEDGAL UL. WASKA 59 BIALYSTOK, 15-122 PL 488-566-32344 / 847-991-6849 |
OSTEOTOME, MANUAL | VARIOUS SIZES OF OSTEOTOMES |
| 30 | MEDICAL MARKETING SPECIALIST INC 331 KINDERSLEY MOUNT-ROYAL,QUEBEC, H3R 1R8 CA 514-739-4010 / 514-739-4010 |
MULTIPLE | VARIOUS TYPES OF OSTEOTOMES |
| 31 | MEDTRONIC XOMED INSTRUMENTATION S.A.S. RUE LE PAVILLON SAINT AUBIN LE MONIAL BOURBON L'ARCHAMBAULT, 03160 FR 763-514-4000 / 904-279-7532 |
MICRO-FRANCE | VARIOUS |
| 32 | MILTEX GMBH MUEHLSTRASSE 6 RIETHEIM- WEILHEIM, D-78604 GM 609-275-0500 / 717-840-3409 |
MULTIPLE | VARIOUS MANUAL OSTEOTOMES |
| 33 | NOPA INSTRUMENTS, MEDIZINTECHNIK GMBH WEILATTEN 7-9 TUTTLINGEN, 78532 GM 004-974-6294900 / 004-974-6294900 |
MULTIPLE | VARIOUS |
| 34 | PMT CORP. 1500 PARK RD. P.O. OX 610 CHANHASSEN, MN 55317 US 800-626-5463 / 800-626-5463 |
TRUBALANCE ANDERSON NEIVERT OSTEOTOME | OSTEOTOME MANUAL |
| 35 | PRECISION MEDICAL MANUFACTURING LLC 852 SETON CT. WHEELING, IL 60090 US 732-326-0032 / 732-326-0032 |
SMALL OSTEOTOME SET | VARIOUS SIZES |
| 36 | ROLAN INSTRUMENTS GMBH 16 SCHLANGENECKSTRASSE ENDINGEN, 79346 GM 49-764-2920516 / 49-764-2920516 |
MULTIPLE | VARIOUS TYPES OF OSTEOTOMES |
| 37 | SKYTEX CORPORATION WAZIRABAD ROAD, P.O.BOX. 490 SIALKOT, PUNJAB, PK 92-52-4262048 / 92-52-4262048 |
OSTEOTOME, MANUAL | OSTEOTOME, MANUAL |
| 38 | SOBYTEK INSTRUMENTS CO. 28-32 SOBY AG BUILDING DASKA SIALKOT, PUNJAB, 51310 PK 92-52-3257062 / 92-52-3257062 |
SURGICAL BONE CUTTERS | SURGICAL BONE CUTTERS |
| 39 | STORK INSTRUMENTE GMBH ENGENERSTR. 29 EMMINGEN-LIPTINGEN 1, 78576 GM 074-65-825 / 49-74-65 2216 |
MULTIPLE | VARIOUS |
| 40 | STRYKER LEIBINGER GMBH & CO. KG BOTZINGER STRASSE 41 FREIBURG, D-79111 GM 269-385-2600 / 49-761-4512x185 |
MULTIPLE | VARIOUS TYPES OF OSTEOTOMES, MANUAL |
| 41 | SURGICON (PVT) LTD. P.O. BOX 244 KHADIM ALI RD. SIALKOT, PUNJAB, PK 92-432-262530 31 / 92-432-262531 32 |
OSTEOTOME MANUAL | OSTEOTOME MANUAL |
| 42 | SURGIPATH MEDICAL INDUSTRIES, INC. 5205 RT. 12 RICHMOND, IL 60071 US 815-678-2000 / 815-678-2000 120 |
OSTEOTOME | OSTEOTOME |
| 43 | SYMMETRY MEDICAL USA, INC. 486 WEST 350 NORTH WARSAW, IN 46582 US 207-786-2775 / 574-371-2213 2213 |
MANUAL SURGICAL INSTRUMENT FOR GENERAL USE | FLEXIBLE OSTEOTOME |
| 44 | TELEFLEX MEDICAL 2917 WECK DR. RESEARCH TRIANGLE PARK, NC 27709 US 919-544-8000 / 919-433-4829 |
MULTIPLE MANUAL OSTEOTOMES | MANUAL OSTEOTOME FOR GENERAL SURGERY |
| 45 | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. ARLINGTON, TN 38002 US 901-867-4732 / 901-867-9971 |
OSTEOTOME | OSTEOTOME |
| 46 | ZIMMER TRABECULAR METAL TECHNOLOGY 10 POMEROY RD. PARSIPPANY, NJ 07054 US 800-613-6131 / 201-818-1800 |
PROXILOCK BOX OSTEOTOME-SMALL | PROXILOCK BOX OSTEOTOME-SMALL |
| 47 | ZOLL DENTAL 7450 NORTH NATCHEZ AVE. NILES, IL 60714 US 847-647-1819 / 847-647-1819 |
OSTEOTOME, MANUAL | VARIOUS TYPES AND STYLES OF OSTEOTOMES |
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