K152187 is an FDA 510(k) clearance for the MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete Cannulated HCS, DuoThread Scarf Screws and TwistCut Snap-Off Screws. This device is classified as a Screw, Fixation, Bone (Class II — Special Controls, product code HWC).
Submitted by Merete Medical GmbH (Berlin, DE). The FDA issued a Cleared decision on February 12, 2016, 191 days after receiving the submission on August 5, 2015.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K152187 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 2015 |
| Decision Date | February 12, 2016 |
| Days to Decision | 191 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HWC — Screw, Fixation, Bone |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 888.3040 |