K132226 is an FDA 510(k) clearance for the METAFIX BLP PLATE, SIZE 31, LEFT, METAFIX BLP PLATE, SIZE 31,RIGHT. This device is classified as a Plate, Fixation, Bone (Class II - Special Controls, product code HRS).
Submitted by Merete Medical GmbH (Berlin, DE). The FDA issued a Cleared decision on August 9, 2013, 23 days after receiving the submission on July 17, 2013.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K132226 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 17, 2013 |
| Decision Date | August 09, 2013 |
| Days to Decision | 23 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | HRS — Plate, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |