K172688 is an FDA 510(k) clearance for the Align Radial Head System. This device is classified as a Prosthesis, Elbow, Hemi-, Radial, Polymer (Class II - Special Controls, product code KWI).
Submitted by Skeletal Dynamics, LLC (Miami, US). The FDA issued a Cleared decision on December 22, 2017, 107 days after receiving the submission on September 6, 2017.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3170.
| 510(k) Number | K172688 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 06, 2017 |
| Decision Date | December 22, 2017 |
| Days to Decision | 107 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWI — Prosthesis, Elbow, Hemi-, Radial, Polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3170 |