K173812 is an FDA 510(k) clearance for the Catalyst CSR 3 Peg Glenoids. This device is classified as a Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented (Class II - Special Controls, product code KWT).
Submitted by Catalyst Orthoscience, Inc. (Naples, US). The FDA issued a Cleared decision on March 9, 2018, 84 days after receiving the submission on December 15, 2017.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3650.
| 510(k) Number | K173812 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 2017 |
| Decision Date | March 09, 2018 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWT - Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3650 |