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FDA 510(k)

Integrity Implant

K-Number: K223538 · 2023-08-17

ApplicantAnika Therapeutics, Inc.
Decision Date2023-08-17
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 2023-08-17 under 510(k) number K223538. 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 2023-08-17. The listed applicant is Anika Therapeutics, Inc.. The 510(k) number is K223538.

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

Integrity Implant received FDA 510(k) clearance on 2023-08-17, under 510(k) number K223538.

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, VISCOELASTICK250997Integrity™ ImplantK231968Tactoset® Injectable Bone SubstitutePMA 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 AGK250997Integrity™ ImplantAnika Therapeutics, Inc.K243480SuturePatch Tissue ReinforcementArthrex, Inc.K241219FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN)ZuriMED 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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