The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Mallory/head Total Hip System.
| Device ID | K853259 |
| 510k Number | K853259 |
| Device Name: | MALLORY/HEAD TOTAL HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Composite/metal |
| Applicant | BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Judith Dermudy |
| Correspondent | Judith Dermudy BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | KMC |
| CFR Regulation Number | 888.3340 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-02 |
| Decision Date | 1985-11-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304256484 | K853259 | 000 |
| 00887868264795 | K853259 | 000 |
| 00887868264801 | K853259 | 000 |
| 00887868308222 | K853259 | 000 |
| 00887868308239 | K853259 | 000 |
| 00887868308246 | K853259 | 000 |
| 00880304045958 | K853259 | 000 |
| 00880304223523 | K853259 | 000 |
| 00880304223530 | K853259 | 000 |
| 00880304223547 | K853259 | 000 |
| 00880304223554 | K853259 | 000 |
| 00880304256446 | K853259 | 000 |
| 00880304256460 | K853259 | 000 |
| 00887868264788 | K853259 | 000 |