K212348 is an FDA 510(k) clearance for the ALPHALOK™ Plating System. This device is classified as a Plate, Fixation, Bone (Class II - Special Controls, product code HRS).
Submitted by Vilex, LLC (Mcminnville, US). The FDA issued a Cleared decision on May 2, 2022, 278 days after receiving the submission on July 28, 2021.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K212348 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 28, 2021 |
| Decision Date | May 02, 2022 |
| Days to Decision | 278 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 |