K120978 is an FDA 510(k) clearance for the OSTEOBRIDGE IKA KNEE ARTHODESIS NAIL WITH COLLAR. 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 May 2, 2012, 30 days after receiving the submission on April 2, 2012.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3020.
| 510(k) Number | K120978 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 02, 2012 |
| Decision Date | May 02, 2012 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | HSB — Rod, Fixation, Intramedullary And Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3020 |