The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Biomet Modular Shoulder Prosthesis.
| Device ID | K872454 |
| 510k Number | K872454 |
| Device Name: | BIOMET MODULAR SHOULDER PROSTHESIS |
| Classification | Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented |
| Applicant | BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Lonnie Witham |
| Correspondent | Lonnie Witham BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | KWT |
| CFR Regulation Number | 888.3650 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-23 |
| Decision Date | 1987-08-27 |