510(k) K241219
K241219 is an FDA 510(k) premarket notification submitted by ZuriMED Technologies AG for the device "FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN)". The FDA issued a decision of Substantially Equivalent on December 11, 2024. The device falls under product code OWX (Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon), a Class II device regulated under 21 CFR 878.3300. ZuriMED Technologies AG has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 11, 2024
- Date Received
- May 1, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- OR
- Submission Type
For reinforcement of soft tissue where weakness exists in tendon repair.