The following data is part of a premarket notification filed by Biomet Inc. with the FDA for Comprehensive Humeral Fracture Positioning Sleeves.
| Device ID | K212435 |
| 510k Number | K212435 |
| Device Name: | Comprehensive Humeral Fracture Positioning Sleeves |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | Biomet Inc. 56 East Bell Drive Warsaw, IN 46581 |
| Contact | Aishwarya Pandey |
| Correspondent | Aishwarya Pandey Biomet INC 56 East Bell Drive Warsaw, IN 46581 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-04 |
| Decision Date | 2021-12-10 |