K803031 is an FDA 510(k) clearance for the LAURE WRIST IMPLANT. This device is classified as a Prosthesis, Wrist, Semi-constrained (Class II - Special Controls, product code KWM).
Submitted by Laure Prosthetics, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 29, 1982, 578 days after receiving the submission on November 28, 1980.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3800.
| 510(k) Number | K803031 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 28, 1980 |
| Decision Date | June 29, 1982 |
| Days to Decision | 578 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | KWM — Prosthesis, Wrist, Semi-constrained |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3800 |