K001706 is an FDA 510(k) clearance for the WMT MODULAR SHOULDER SYSTEM. This device is classified as a Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (Class II - Special Controls, product code KWS).
Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on August 16, 2000, 72 days after receiving the submission on June 5, 2000.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3660.
| 510(k) Number | K001706 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 05, 2000 |
| Decision Date | August 16, 2000 |
| Days to Decision | 72 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 |