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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 the device name listed in this FDA 510(k) record. The listed applicant is Anika Therapeutics, Inc.. It received FDA 510(k) clearance on 2025-06-17 under 510(k) 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. The listed applicant is Anika Therapeutics, Inc.. The 510(k) number is K250997.

When did Integrity™ Implant receive FDA 510(k) clearance?

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

Who is the listed applicant for Integrity™ Implant?

The FDA 510(k) record lists Anika Therapeutics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Integrity™ Implant?

The FDA product code for Integrity™ Implant 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.

NCT06741527Integrity Implant System Post Market Clinical Follow-Up StudyRECRUITING

Other records listing Anika Therapeutics, Inc. 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.

PMA P000046AID, SURGICAL, VISCOELASTICK231968Tactoset® Injectable Bone SubstituteK223538Integrity ImplantPMA P090031Acid, hyaluronic, intraarticularK223860Integrity™ Bone Staple Fixation SystemK222487Anika Tissue Tack Fixation System

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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 AGK243480SuturePatch 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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