K241219 is an FDA 510(k) clearance for the FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN). This device is classified as a Mesh, Surgical, Non-absorbable, Orthopaedics, Reinforcement Of Tendon (Class II - Special Controls, product code OWX).
Submitted by ZuriMED Technologies AG (Zurich, CH). The FDA issued a Cleared decision on December 11, 2024, 224 days after receiving the submission on May 1, 2024.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 878.3300. For Reinforcement Of Soft Tissue Where Weakness Exists In Tendon Repair..
| 510(k) Number | K241219 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 2024 |
| Decision Date | December 11, 2024 |
| Days to Decision | 224 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | OWX - Mesh, Surgical, Non-absorbable, Orthopaedics, Reinforcement Of Tendon |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |
| Definition | For Reinforcement Of Soft Tissue Where Weakness Exists In Tendon Repair. |