The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Bio-modular Shoulder Offset Humeral Heads.
| Device ID | K992899 |
| 510k Number | K992899 |
| Device Name: | BIO-MODULAR SHOULDER OFFSET HUMERAL HEADS |
| Classification | Prosthesis, Shoulder, 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 | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-30 |
| Decision Date | 1999-10-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304214477 | K992899 | 000 |
| 00880304214460 | K992899 | 000 |
| 00880304214453 | K992899 | 000 |
| 00880304214446 | K992899 | 000 |
| 00880304214439 | K992899 | 000 |
| 00880304214422 | K992899 | 000 |
| 00880304214415 | K992899 | 000 |
| 00880304214392 | K992899 | 000 |
| 00880304214378 | K992899 | 000 |