K163397 is an FDA 510(k) clearance for the SMR Hybrid Glenoid System. This device is classified as a Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented (Class II - Special Controls, product code MBF).
Submitted by Lima Corporate S.P.A. (Villanova Di San Daniele Udine, IT). The FDA issued a Cleared decision on June 29, 2017, 206 days after receiving the submission on December 5, 2016.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3670.
| 510(k) Number | K163397 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 05, 2016 |
| Decision Date | June 29, 2017 |
| Days to Decision | 206 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 |