K081106 is an FDA 510(k) clearance for the PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM VOLAR DISTAL RADIUS LOCKING PLATE FOR THE UPPER EXTREMITY-ASTM F139. This device is classified as a Plate, Fixation, Bone (Class II - Special Controls, product code HRS).
Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on June 18, 2008, 61 days after receiving the submission on April 18, 2008.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K081106 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 18, 2008 |
| Decision Date | June 18, 2008 |
| Days to Decision | 61 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HRS — Plate, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |