FDA 510(k) Applications for Medical Device:
Bone Cement, Antibiotic
| FDA 510(k) Number |
Applicant |
Address |
City / Country |
State / Province |
Postal Code |
| K131135 |
BIOMET MANUFACTURING CORP. |
56 EAST BELL DRIVE
| WARSAW |
IN |
46581-0587 |
| K150850 |
BIOMET, INC. |
56 EAST BELL DRIVE
| WARSAW |
IN |
46581 |
| K160071 |
Biomet, Inc. |
56 East Bell Drive
| Warsaw |
IN |
46581 |
| K161273 |
Biomet, Inc. |
56 East Bell Drive
| Warsaw |
IN |
46581 |
| K213287 |
Biomet, Inc. |
56 East Bell Drive
| Warsaw |
IN |
46581 |
| K161166 |
BIOMET, INC. |
56 EAST BELL DRIVE
| Warsaw |
IN |
46581 |
| K222760 |
Biomet, Inc. |
56 East Bell Drive, P.O. Box 587
| Warsaw |
IN |
46581 |
| K221968 |
Biomet, Inc. |
56 East Bell Drive, P.O. Box 587
| Warsaw |
IN |
46581 |
| K053002 |
DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE
| WARSAW |
IN |
46581-0988 |
| K061144 |
DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DR.
| WARSAW |
IN |
46581-0988 |
| K081163 |
DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE
| WARSAW |
IN |
46581-0988 |
| K192041 |
G21 S.r.l |
Via Sandro Petrini, 8
| San Possidonio |
|
41039 |
| K190216 |
G21 S.R.L |
Via Sandro Petrini, 8
| San Possidonio |
|
41039 |
| K201960 |
G21 S.r.l |
Via Sandro Petrini, 8
| San Possidonio |
|
41039 |
| K202338 |
G21 Srl |
Via Sandro Pertini, 8
| San Possidonio |
|
41039 |
| K063857 |
HOWMEDICA OSTEONICS CORP. |
325 CORPORATE DR
| MAHWAH |
NJ |
07430 |
| K240856 |
Osartis GmbH |
Auf der Beune 101
| Munster |
|
64839 |
| K242216 |
Teknimed SAS |
11-12 Rue d'Apollo
| L'Union |
|
31240 |
|
|