K221366 is an FDA 510(k) clearance for the Smart Correction System Rings and Compatible HA-Coated Half Pins. This device is classified as a Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (Class II - Special Controls, product code KTT).
Submitted by Wishbone Medical, Inc. (Warsaw, US). The FDA issued a Cleared decision on June 6, 2022, 25 days after receiving the submission on May 12, 2022.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K221366 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 12, 2022 |
| Decision Date | June 06, 2022 |
| Days to Decision | 25 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KTT - Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |