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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 the device name listed in this FDA 510(k) record. The listed applicant is ZuriMED Technologies AG. It received FDA 510(k) clearance on 2024-12-11 under 510(k) 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. The listed applicant is ZuriMED Technologies AG. The 510(k) number is K241219.

When did FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN) receive FDA 510(k) clearance?

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

Who is the listed applicant for FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN)?

The FDA 510(k) record lists ZuriMED Technologies AG as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06918041FiberLocker® System Augmentation of Rotator Cuff RepairsRECRUITING

Other records listing ZuriMED Technologies AG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253867FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit

Related Devices (Code: OWX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253867FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnitZuriMED Technologies AGK250997Integrity™ ImplantAnika Therapeutics, Inc.K243480SuturePatch Tissue ReinforcementArthrex, Inc.K223538Integrity ImplantAnika Therapeutics, Inc.

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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