K221968 is an FDA 510(k) clearance for the StageOne™ Shoulder Cement Spacer Molds. This device is classified as a Bone Cement, Antibiotic (Class II - Special Controls, product code MBB).
Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on September 15, 2022, 72 days after receiving the submission on July 5, 2022.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3027.
| 510(k) Number | K221968 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 05, 2022 |
| Decision Date | September 15, 2022 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MBB — Bone Cement, Antibiotic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3027 |