The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Stageone Knee Cement Spacer Molds.
| Device ID | K213287 |
| 510k Number | K213287 |
| Device Name: | StageOne Knee Cement Spacer Molds |
| Classification | Bone Cement, Antibiotic |
| Applicant | Biomet, Inc. 56 East Bell Drive Warsaw, IN 46581 |
| Contact | Anuja Yardi |
| Correspondent | Neha Sreenath Biomet, Inc. 56 East Bell Drive Warsaw, IN 46581 |
| Product Code | MBB |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-01 |
| Decision Date | 2022-09-02 |