K193497 is an FDA 510(k) clearance for the Fixone Biocomposite Interference Screw. This device is classified as a Screw, Fixation, Bone (Class II - Special Controls, product code HWC).
Submitted by Aju Pharm Co., Ltd. (Seongnam-Si, KR). The FDA issued a Cleared decision on January 5, 2021, 385 days after receiving the submission on December 17, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K193497 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 2019 |
| Decision Date | January 05, 2021 |
| Days to Decision | 385 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HWC - Screw, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |