FDA 510(k) Applications for Medical Device:
Cement Obturator
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K993841 | ENCORE ORTHOPEDICS, INC. |
9800 METRIC BLVD. | AUSTIN | TX | 78758 |
| K992462 | HOWMEDICA OSTEONICS CORP. |
59 ROUTE 17 SOUTH | ALLENDALE | NJ | 07401-1677 |
| K220838 | Howmedica Osteonics, dba Stryker Orthopaedics |
325 Corporate Drive | Mahwah | NJ | 07430 |
| K000587 | ISOTIS NV |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K010840 | ISOTIS NV |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K011943 | KENSEY NASH CORP. |
55 EAST UWCHLAN AVE. | EXTON | PA | 19341-1247 |
| K955751 | ORTHOPAEDIC INNOVATIONS, INC. |
825 SOUTH 8TH ST. | MINNEAPOLIS | MN | 55404 |
| K970779 | OSTEONICS CORP. |
59 ROUTE 17 | ALLENDALE | NJ | 07401-1677 |
| K023680 | SMITH & NEPHEW, INC. |
1450 BROOKS RD. | MEMPHIS | TN | 38116 |
| K955631 | SUNMED, INC. |
3711 MEADOWVIEW DR., SUITE 100 | REDDING | CA | 96002 |
| K955632 | SUNMED, INC. |
3711 MEADOWVIEW DR., SUITE 100 | REDDING | CA | 96002 |
| K032685 | TEKNIMED SA |
1001 OAKWOOD BLVD | ROUND ROCK | TX | 78681 |
| K061824 | TORNIER |
161 RUE LAVOISIER | SAINT-ISMIER CEDEX | 38334 | |
| K972411 | TURNKEY INTERGRATION USA, INC. |
321 PALMER RD. | DENVILLE | NJ | 07834 |
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