K153207 is an FDA 510(k) clearance for the Additive Orthopaedics Bone Wedge System. This device is classified as a Plate, Fixation, Bone (Class II - Special Controls, product code HRS).
Submitted by Additive Orthopaedics, LLC (Little Silver, US). The FDA issued a Cleared decision on September 7, 2016, 307 days after receiving the submission on November 5, 2015.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K153207 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 2015 |
| Decision Date | September 07, 2016 |
| Days to Decision | 307 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 |