K150675 is an FDA 510(k) clearance for the Dorsal Spanning Plate. This device is classified as a Plate, Fixation, Bone (Class II — Special Controls, product code HRS).
Submitted by Skeletal Dynamics, LLC (Miami, US). The FDA issued a Cleared decision on May 12, 2015, 57 days after receiving the submission on March 16, 2015.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K150675 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 16, 2015 |
| Decision Date | May 12, 2015 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HRS — Plate, Fixation, Bone |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 888.3030 |