The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Stageone Disposable Cement Spacer Molds For Temporary Hemi-shoulder Prosthesis.
| Device ID | K160071 |
| 510k Number | K160071 |
| Device Name: | StageOne Disposable Cement Spacer Molds For Temporary Hemi-Shoulder Prosthesis |
| Classification | Bone Cement, Antibiotic |
| Applicant | Biomet, Inc. 56 East Bell Drive Warsaw, IN 46581 |
| Contact | Carmen Albany |
| Correspondent | Heidi Busz Biomet, Inc. 56 East Bell Drive Warsaw, IN 46581 |
| Product Code | MBB |
| Subsequent Product Code | HSD |
| Subsequent Product Code | KWS |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2016-01-13 |
| Decision Date | 2016-06-16 |
| Summary: | summary |