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FDA 510(k)

FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit

K-Number: K253867 · 2026-01-02

ApplicantZuriMED Technologies AG
Decision Date2026-01-02
Product CodeOWX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit 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 2026-01-02 under 510(k) number K253867. 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 Implant ; FiberLocker Instrument ; FiberLocker PowerUnit?

FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit is a medical device that received FDA 510(k) clearance on 2026-01-02. The listed applicant is ZuriMED Technologies AG. The 510(k) number is K253867.

When did FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit receive FDA 510(k) clearance?

FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit received FDA 510(k) clearance on 2026-01-02, under 510(k) number K253867.

Who is the listed applicant for FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit?

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 Implant ; FiberLocker Instrument ; FiberLocker PowerUnit?

The FDA product code for FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit 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.

K241219FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN)

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.

K250997Integrity™ ImplantAnika Therapeutics, Inc.K243480SuturePatch Tissue ReinforcementArthrex, Inc.K241219FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN)ZuriMED Technologies AGK223538Integrity 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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