FDA 510(k) Applications for Medical Device:
Fastener, Plate, Cranioplasty
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K001353 | BIOMEDICAL ENT., INC. |
14785 OMICRON DR., SUITE 205 | SAN ANTONIO | TX | 78245 |
| K141385 | DEPUY SYNTHES COMPANIES OF JOHNSON & JOHNSON |
1230 WILSON DRIVE | WEST CHESTER | PA | 19380 |
| K101835 | POREX SURGICAL, INC. |
15 DART RD. | NEWNAN | GA | 30265 |
| K171152 | Stryker |
750 Trade Centre Way, Suite 200 | Portage | MI | 49002 |
| K151387 | STRYKER |
750 TRADE CENTRE WAY, SUITE 200 | PORTAGE | MI | 49002 |
| K231208 | Stryker Leibinger GmbH & Co. KG |
Boetzinger Strasse 41 | Freiburg |
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