K213785 is an FDA 510(k) clearance for the SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid. This device is classified as a Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (Class II - Special Controls, product code KWS).
Submitted by Limacorporate (Villanova Di San Daniele Del Friuli, IT). The FDA issued a Cleared decision on May 13, 2022, 158 days after receiving the submission on December 6, 2021.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3660.
| 510(k) Number | K213785 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 06, 2021 |
| Decision Date | May 13, 2022 |
| Days to Decision | 158 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWS - Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3660 |