The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Co-cr Answer Femoral Component.
| Device ID | K931194 |
| 510k Number | K931194 |
| Device Name: | CO-CR ANSWER FEMORAL COMPONENT |
| Classification | Prosthesis, Hip, Femoral Component, Cemented, Metal |
| Applicant | BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK Warsaw, IN 46581 -0587 |
| Contact | Dutch Harrison |
| Correspondent | Dutch Harrison BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK 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 | 1993-03-09 |
| Decision Date | 1994-05-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304252820 | K931194 | 000 |
| 00880304005365 | K931194 | 000 |
| 00880304009158 | K931194 | 000 |
| 00880304010604 | K931194 | 000 |
| 00880304222649 | K931194 | 000 |
| 00880304222656 | K931194 | 000 |
| 00880304222663 | K931194 | 000 |
| 00880304222687 | K931194 | 000 |
| 00880304222700 | K931194 | 000 |
| 00880304222717 | K931194 | 000 |
| 00880304252660 | K931194 | 000 |
| 00880304252684 | K931194 | 000 |
| 00880304252707 | K931194 | 000 |
| 00880304252714 | K931194 | 000 |
| 00880304252776 | K931194 | 000 |
| 00880304001947 | K931194 | 000 |