K140283 is an FDA 510(k) clearance for the OSTEOMED EXTREMIFUSE SYSTEM. This device is classified as a Screw, Fixation, Bone (Class II - Special Controls, product code HWC).
Submitted by Osteomed (Addison, US). The FDA issued a Cleared decision on February 28, 2014, 24 days after receiving the submission on February 4, 2014.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K140283 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 2014 |
| Decision Date | February 28, 2014 |
| Days to Decision | 24 days |
| Submission Type | Special |
| 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 |