K083032 is an FDA 510(k) clearance for the PERI-LOC BONE PLATING AND SCREW SYSTEM. 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 January 7, 2009, 89 days after receiving the submission on October 10, 2008.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K083032 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 10, 2008 |
| Decision Date | January 07, 2009 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| 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 |