The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Cobalt-chromium-molybdenum (co-cr-mo) Alloy Femoral Heads W/co-nidium Surface Treatment.
| Device ID | K960278 |
| 510k Number | K960278 |
| Device Name: | COBALT-CHROMIUM-MOLYBDENUM (CO-CR-MO) ALLOY FEMORAL HEADS W/CO-NIDIUM SURFACE TREATMENT |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Lynette Whitaker |
| Correspondent | Lynette Whitaker ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-19 |
| Decision Date | 1996-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024156159 | K960278 | 000 |
| 00889024156135 | K960278 | 000 |
| 00889024156111 | K960278 | 000 |
| 00889024156104 | K960278 | 000 |
| 00889024156081 | K960278 | 000 |
| 00889024156067 | K960278 | 000 |
| 00889024156050 | K960278 | 000 |
| 00889024156036 | K960278 | 000 |
| 00889024156012 | K960278 | 000 |