The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Fine Grain Cast Cobalt Chromium Hip Stems.
| Device ID | K953925 |
| 510k Number | K953925 |
| Device Name: | FINE GRAIN CAST COBALT CHROMIUM HIP STEMS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK Warsaw, IN 46581 |
| Contact | Lisana W Mann |
| Correspondent | Lisana W Mann BIOMET, INC. AIRPORT INDUSTRIAL PARK Warsaw, IN 46581 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-18 |
| Decision Date | 1996-01-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304254220 | K953925 | 000 |
| 00880304254114 | K953925 | 000 |
| 00880304254152 | K953925 | 000 |
| 00880304254183 | K953925 | 000 |
| 00880304254213 | K953925 | 000 |
| 00880304002777 | K953925 | 000 |
| 00880304002784 | K953925 | 000 |
| 00880304004016 | K953925 | 000 |
| 00880304254138 | K953925 | 000 |
| 00880304254206 | K953925 | 000 |
| 00880304254084 | K953925 | 000 |