Cleared Traditional

FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN)

K241219 · ZuriMED Technologies AG · Orthopedic
Dec 2024
Decision
224d
Days
Class 2
Risk

About This 510(k) Submission

K241219 is an FDA 510(k) clearance for the FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN), 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 review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number K241219 FDA.gov
FDA Decision Cleared 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

Device Classification

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.