K851349 is an FDA 510(k) clearance for the LERE NAIL & PLATE COMBIN. ONE PIECE FORGED. This device is classified as a Appliance, Fixation, Nail/blade/plate Combination, Single Component (Class II - Special Controls, product code KTW).
Submitted by Medicalex (Paris 75013, FR). The FDA issued a Cleared decision on May 29, 1985, 55 days after receiving the submission on April 4, 1985.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K851349 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 1985 |
| Decision Date | May 29, 1985 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | KTW — Appliance, Fixation, Nail/blade/plate Combination, Single Component |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |