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FDA 510(k)

Integrity™ Implant

K-Number: K250997 · 2025-06-17

ApplicantAnika Therapeutics, Inc.
Decision Date2025-06-17
Product CodeOWX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Integrity™ Implant is a medical device manufactured by Anika Therapeutics, Inc.. It received FDA 510(k) clearance on 2025-06-17 under approval number K250997. 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 Integrity™ Implant?

Integrity™ Implant is a medical device that received FDA 510(k) clearance on 2025-06-17. It is manufactured by Anika Therapeutics, Inc.. The 510(k) number is K250997.

When was Integrity™ Implant approved by the FDA?

Integrity™ Implant received FDA 510(k) clearance on 2025-06-17, under approval number K250997.

What company makes Integrity™ Implant?

Integrity™ Implant is manufactured by Anika Therapeutics, Inc..

What is the FDA product code for Integrity™ Implant?

The FDA product code for Integrity™ Implant is OWX.

Related Clinical Trials

NCT05735119 Embody Post-Market Clinical Follow-Up Study ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 41966215 Advancing Public Health Through Internationally Coordinated Medical Device Registries 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 (2026)

Other Devices by Anika Therapeutics, Inc.

K173008SCS 17-01 K190956SCS 17-01 K212083Tactoset Injectable Bone Substitute K231968Tactoset® Injectable Bone Substitute K223538Integrity Implant K223860Integrity™ Bone Staple Fixation System

View all 12 devices →

Related Devices (Code: OWX)

K223538Integrity ImplantAnika Therapeutics, Inc. K241219FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN)ZuriMED Technologies AG 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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