K151021 is an FDA 510(k) clearance for the OsteoMed Cannulated Screw System. This device is classified as a Screw, Fixation, Bone (Class II — Special Controls, product code HWC).
Submitted by Osteomed Corp. (Addison, US). The FDA issued a Cleared decision on July 15, 2015, 90 days after receiving the submission on April 16, 2015.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K151021 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 16, 2015 |
| Decision Date | July 15, 2015 |
| Days to Decision | 90 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 |