FDA 510(k) Applications for Medical Device:
Prosthesis, Hip, Hemi-, Femoral, Metal
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K984028 | BIOMET, INC. |
AIRPORT INDUSTRIAL PARK, | WARSAW | IN | 46581-0587 |
| K111911 | CORIN U.S.A. |
10500 UNIVERSITY CENTER DR., | TAMPA | FL | 33612 |
| K063791 | CORIN USA |
10500 UNIVERSITY CENTER DRIVE | TAMPA | FL | 33612 |
| K030972 | DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. |
3 HASADNAOT | HERZELIA | 46728 | |
| K973614 | ENCORE ORTHOPEDICS, INC. |
9800 METRIC BLVD. | AUSTIN | TX | 78758 |
| K960538 | EXACTECH, INC. |
4613 N.W. 6TH STREET, SUITE D | GAINESVILLE | FL | 32609 |
| K031841 | EXACTECH, INC. |
2320 N.W. 66TH CT. | GAINESVILLE | FL | 32653 |
| K030205 | HAYES MEDICAL, INC. |
1115 WINDFIELD WAY, SUITE 100 | EL DORADO HILLS | CA | 95762-9623 |
| K071471 | HOWMEDICA OSTEONICS CORP |
325 CORPORATE DR. | MAHWAH | NJ | 07430 |
| K992570 | HOWMEDICA OSTEONICS CORP. |
59 ROUTE 17 SOUTH | ALLENDALE | NJ | 07401-1677 |
| K014226 | HOWMEDICA OSTEONICS CORP. |
59 ROUTE 17 SOUTH | ALLENDALE | NJ | 07401-1677 |
| K222632 | Howmedica Osteonics Corp., dba Stryker Orthopaedics |
325 Corporate Drive | Mahwah | NJ | 07430 |
| K965198 | JOHNSON & JOHNSON INTERNATIONAL |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767-0350 |
| K955385 | JOHNSON & JOHNSON PROFESSIONALS, INC. |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767-0350 |
| K965156 | JOHNSON & JOHNSON PROFESSIONALS, INC. |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767-0350 |
| K112470 | MANDELL HORWITZ CONSULTANTS LLC |
2995 STEVEN MARTIN DR | FAIRFAX | VA | 22031 |
| K042973 | ORTHO DEVELOPMENT CORP. |
12187 SOUTH BUSINESS PARK DR. | DRAPER | UT | 84020 |
| K962646 | ORTHOPAEDIC INNOVATIONS, INC. |
825 SOUTH 8TH ST. | MINNEAPOLIS | MN | 55404 |
| K974807 | OSTEONICS CORP. |
59 ROUTE 17 | ALLENDALE | NJ | 07401-1677 |
| K984585 | OSTEONICS CORP. |
59 ROUTE 17 | ALLENDALE | NJ | 07401-1677 |
| K173967 | Osteoremedies LLC |
6800 Poplar Avenue | Memphis | TN | 38138 |
| K192995 | OsteoRemedies, LLC |
6800 Poplar Avenue, #120 | Germantown | TN | 38138 |
| K191981 | OsteoRemedies, LLC |
6800 Poplar Avenue, #120 | Germantown | TN | 38138 |
| K172906 | OsteoRemedies, LLC |
6800 Poplar Avenue, #120 | Germantown | TN | 38138 |
| K990309 | PLUS ORTHOPEDICS |
3550 GENERAL ATOMICS CT. | SAN DIEGO | CA | 92121-1194 |
| K143184 | Signature Orthopaedics Pty Ltd. |
7 Sirius Road | Lane Cove | 2066 | |
| K062408 | SMITH & NEPHEW, INC. |
1450 BROOKS RD. | MEMPHIS | TN | 38116 |
| K061243 | SMITH & NEPHEW, INC. |
1450 BROOKS RD. | MEMPHIS | TN | 38116 |
| K981451 | STELKAST COMPANY |
800 VINIAL ST. #210 | PITTSBURGH | PA | 15212 |
| K101356 | TECRES SPA |
7 Trail House Court | Rockville | MD | 20850 |
| K062273 | TECRES SPA |
2320 N.W. 66TH COURT | GAINESVILLE | FL | 32653 |
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