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FDA 510(k)

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

K-Number: K241219 · 2024-12-11

ApplicantZuriMED Technologies AG
Decision Date2024-12-11
Product CodeOWX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN) is a medical device manufactured by ZuriMED Technologies AG. It received FDA 510(k) clearance on 2024-12-11 under approval number K241219. The device is classified under product code OWX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN)?

FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN) is a medical device that received FDA 510(k) clearance on 2024-12-11. It is manufactured by ZuriMED Technologies AG. The 510(k) number is K241219.

When was FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN) approved by the FDA?

FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN) received FDA 510(k) clearance on 2024-12-11, under approval number K241219.

What company makes FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN)?

FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN) is manufactured by ZuriMED Technologies AG.

What is the FDA product code for FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN)?

The FDA product code for FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN) is OWX.

Related Clinical Trials

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Related PubMed Literature

PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025) PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by ZuriMED Technologies AG

K253867FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit

Related Devices (Code: OWX)

K223538Integrity ImplantAnika Therapeutics, Inc. K250997Integrity™ ImplantAnika Therapeutics, Inc. K243480SuturePatch Tissue ReinforcementArthrex, Inc. K253867FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnitZuriMED Technologies AG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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