K120667 is an FDA 510(k) clearance for the VLP 2.7MM EXTRA LARGE PERCUTANEOUS CALCANEUS PLATE, PERI-LOC 3.5MM ANTERIOR ANKLE FUSION PLATES, PERI-LOC 3.5MM HINDFOOT. 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 April 4, 2012, 30 days after receiving the submission on March 5, 2012.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K120667 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 05, 2012 |
| Decision Date | April 04, 2012 |
| Days to Decision | 30 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 |