K160071 is an FDA 510(k) clearance for the StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis. 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 June 16, 2016, 155 days after receiving the submission on January 13, 2016.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3027.
| 510(k) Number | K160071 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 13, 2016 |
| Decision Date | June 16, 2016 |
| Days to Decision | 155 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 |