The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Integral Co-cr Femoral Component.
| Device ID | K942479 |
| 510k Number | K942479 |
| Device Name: | INTEGRAL CO-CR FEMORAL COMPONENT |
| Classification | Prosthesis, Hip, Femoral Component, Cemented, Metal |
| Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Patricia Sandborn Beres |
| Correspondent | Patricia Sandborn Beres BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | JDG |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-25 |
| Decision Date | 1994-09-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304253223 | K942479 | 000 |
| 00880304223271 | K942479 | 000 |
| 00880304208728 | K942479 | 000 |
| 00880304208711 | K942479 | 000 |
| 00880304208681 | K942479 | 000 |
| 00880304208667 | K942479 | 000 |
| 00880304009189 | K942479 | 000 |
| 00880304005792 | K942479 | 000 |
| 00880304001169 | K942479 | 000 |
| 00880304001121 | K942479 | 000 |
| 00887868273247 | K942479 | 000 |
| 00880304223295 | K942479 | 000 |
| 00880304223318 | K942479 | 000 |
| 00880304253216 | K942479 | 000 |
| 00880304253162 | K942479 | 000 |
| 00880304253131 | K942479 | 000 |
| 00880304253124 | K942479 | 000 |
| 00880304253117 | K942479 | 000 |
| 00880304253100 | K942479 | 000 |
| 00880304253094 | K942479 | 000 |
| 00880304253087 | K942479 | 000 |
| 00880304223356 | K942479 | 000 |
| 00880304223332 | K942479 | 000 |
| 00887868273223 | K942479 | 000 |