The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Shp Hip System-femoral Components/acetabular Components/modular Heads/centralizers.
| Device ID | K960984 |
| 510k Number | K960984 |
| Device Name: | SHP HIP SYSTEM-FEMORAL COMPONENTS/ACETABULAR COMPONENTS/MODULAR HEADS/CENTRALIZERS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| 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 | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-11 |
| Decision Date | 1996-09-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304255593 | K960984 | 000 |
| 00880304255494 | K960984 | 000 |
| 00880304255500 | K960984 | 000 |
| 00880304255517 | K960984 | 000 |
| 00880304255524 | K960984 | 000 |
| 00880304255531 | K960984 | 000 |
| 00880304255548 | K960984 | 000 |
| 00880304255555 | K960984 | 000 |
| 00880304255579 | K960984 | 000 |
| 00880304255586 | K960984 | 000 |
| 00880304255487 | K960984 | 000 |