The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Bi-angular Shoulder System.
| Device ID | K032895 |
| 510k Number | K032895 |
| Device Name: | BI-ANGULAR SHOULDER SYSTEM |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented |
| Applicant | BIOMET, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Patricia S Beres |
| Correspondent | Patricia S Beres BIOMET, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | MBF |
| CFR Regulation Number | 888.3670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-17 |
| Decision Date | 2003-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304215030 | K032895 | 000 |
| 00880304006966 | K032895 | 000 |
| 00880304003934 | K032895 | 000 |
| 00880304003767 | K032895 | 000 |
| 00880304003484 | K032895 | 000 |
| 00880304003453 | K032895 | 000 |
| 00880304002739 | K032895 | 000 |
| 00880304002531 | K032895 | 000 |
| 00880304001329 | K032895 | 000 |
| 00880304001275 | K032895 | 000 |
| 00880304007055 | K032895 | 000 |
| 00880304009622 | K032895 | 000 |
| 00880304214842 | K032895 | 000 |
| 00880304215023 | K032895 | 000 |
| 00880304215016 | K032895 | 000 |
| 00880304214996 | K032895 | 000 |
| 00880304214903 | K032895 | 000 |
| 00880304214897 | K032895 | 000 |
| 00880304214880 | K032895 | 000 |
| 00880304214873 | K032895 | 000 |
| 00880304214866 | K032895 | 000 |
| 00880304214859 | K032895 | 000 |
| 00880304000322 | K032895 | 000 |