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FDA 510(k)

Integrity Implant

K-Number: K223538 · 2023-08-17

Decision Date2023-08-17
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 2023-08-17 under approval 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. It is manufactured by Anika Therapeutics, Inc.. The 510(k) number is K223538.

When was Integrity Implant approved by the FDA?

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

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

Other Devices by Anika Therapeutics, Inc.

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Related Devices (Code: OWX)

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.