K142451 is an FDA 510(k) clearance for the OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System. This device is classified as a Rod, Fixation, Intramedullary And Accessories (Class II - Special Controls, product code HSB).
Submitted by Merete Medical GmbH (Berlin, DE). The FDA issued a Cleared decision on February 9, 2015, 160 days after receiving the submission on September 2, 2014.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3020.
| 510(k) Number | K142451 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 02, 2014 |
| Decision Date | February 09, 2015 |
| Days to Decision | 160 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HSB — Rod, Fixation, Intramedullary And Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3020 |