K192484 is an FDA 510(k) clearance for the Fixone Biocomposite Anchor. This device is classified as a Fastener, Fixation, Biodegradable, Soft Tissue (Class II - Special Controls, product code MAI).
Submitted by Aju Pharm Co., Ltd. (Seongnam-Si, KR). The FDA issued a Cleared decision on March 11, 2020, 183 days after receiving the submission on September 10, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K192484 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 10, 2019 |
| Decision Date | March 11, 2020 |
| Days to Decision | 183 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MAI - Fastener, Fixation, Biodegradable, Soft Tissue |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |