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FDA 510(k)

Integrity Retractable Implant Inserter (6000127)

K-Number: K261869 · 2026-09-17

ApplicantAnika Therapeutics, Inc.
Decision Date2026-09-17
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Integrity Retractable Implant Inserter (6000127) 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 2026-09-17 under 510(k) number K261869. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Integrity Retractable Implant Inserter (6000127)?

Integrity Retractable Implant Inserter (6000127) is a medical device that received FDA 510(k) clearance on 2026-09-17. The listed applicant is Anika Therapeutics, Inc.. The 510(k) number is K261869.

When did Integrity Retractable Implant Inserter (6000127) receive FDA 510(k) clearance?

Integrity Retractable Implant Inserter (6000127) received FDA 510(k) clearance on 2026-09-17, under 510(k) number K261869.

Who is the listed applicant for Integrity Retractable Implant Inserter (6000127)?

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 Retractable Implant Inserter (6000127)?

The FDA product code for Integrity Retractable Implant Inserter (6000127) is MBI.

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

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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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