K182285 is an FDA 510(k) clearance for the PK High Tibial Osteotomy Correction System. This device is classified as a Appliance, Fixation, Nail/blade/plate Combination, Single Component (Class II - Special Controls, product code KTW).
Submitted by Paonan Biotech Co., Ltd. (Taipei City, TW). The FDA issued a Cleared decision on June 20, 2019, 301 days after receiving the submission on August 23, 2018.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K182285 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 23, 2018 |
| Decision Date | June 20, 2019 |
| Days to Decision | 301 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KTW — Appliance, Fixation, Nail/blade/plate Combination, Single Component |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |