The following data is part of a premarket notification filed by Biomet Inc. with the FDA for A.l.p.s. Clavicle Plating System.
| Device ID | K210192 |
| 510k Number | K210192 |
| Device Name: | A.L.P.S. Clavicle Plating System |
| Classification | Plate, Fixation, Bone |
| Applicant | Biomet Inc. 56 East Bell Drive Warsaw, IN 46581 |
| Contact | Kyle Ponce |
| Correspondent | Kyle Ponce Biomet Inc. 56 East Bell Drive Warsaw, IN 46581 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-25 |
| Decision Date | 2021-02-19 |