K233601 is an FDA 510(k) clearance for the Fixone Meniscal Repair. This device is classified as a Fastener, Fixation, Nondegradable, Soft Tissue (Class II - Special Controls, product code MBI).
Submitted by Aju Pharm Co., Ltd. (Seongnam, KR). The FDA issued a Cleared decision on August 2, 2024, 267 days after receiving the submission on November 9, 2023.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K233601 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 09, 2023 |
| Decision Date | August 02, 2024 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MBI - Fastener, Fixation, Nondegradable, Soft Tissue |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |