The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Bio-modular Shoulder System.
| Device ID | K992119 |
| 510k Number | K992119 |
| Device Name: | BIO-MODULAR SHOULDER SYSTEM |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Patricia Sandborn Beres |
| Correspondent | Patricia Sandborn Beres BIOMET, INC. 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 | 1999-06-23 |
| Decision Date | 1999-09-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304214125 | K992119 | 000 |
| 00880304214101 | K992119 | 000 |
| 00880304116139 | K992119 | 000 |
| 00880304116122 | K992119 | 000 |