K193038 is an FDA 510(k) clearance for the Comprehensive Shoulder System. This device is classified as a Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented (Class II - Special Controls, product code MBF).
Submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on October 28, 2020, 363 days after receiving the submission on October 31, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3670.
| 510(k) Number | K193038 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 31, 2019 |
| Decision Date | October 28, 2020 |
| Days to Decision | 363 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MBF — Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3670 |