K203230 is an FDA 510(k) clearance for the Global Shoulder and Delta CTA systems. This device is classified as a Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (Class II - Special Controls, product code KWS).
Submitted by Depuy Lnc. (Warsaw, US). The FDA issued a Cleared decision on April 2, 2021, 151 days after receiving the submission on November 2, 2020.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3660.
| 510(k) Number | K203230 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 2020 |
| Decision Date | April 02, 2021 |
| Days to Decision | 151 days |
| Submission Type | Traditional |
| 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 |