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FDA 510(k)

Anika Tissue Tack Fixation System

K-Number: K222487 · 2023-05-08

ApplicantAnika Therapeutics, Inc.
Decision Date2023-05-08
Product CodeGDW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Anika Tissue Tack Fixation System is a medical device manufactured by Anika Therapeutics, Inc.. It received FDA 510(k) clearance on 2023-05-08 under approval number K222487. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Anika Tissue Tack Fixation System?

Anika Tissue Tack Fixation System is a medical device that received FDA 510(k) clearance on 2023-05-08. It is manufactured by Anika Therapeutics, Inc.. The 510(k) number is K222487.

When was Anika Tissue Tack Fixation System approved by the FDA?

Anika Tissue Tack Fixation System received FDA 510(k) clearance on 2023-05-08, under approval number K222487.

What company makes Anika Tissue Tack Fixation System?

Anika Tissue Tack Fixation System is manufactured by Anika Therapeutics, Inc..

What is the FDA product code for Anika Tissue Tack Fixation System?

The FDA product code for Anika Tissue Tack Fixation System is GDW.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT07608939 Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers NOT_YET_RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT07278869 Applause Study I - Append System Early Feasibility Study RECRUITING

Related PubMed Literature

PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026) PMID: 40942702 Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health. Sensors (Basel, Switzerland) (2025)

Other Devices by Anika Therapeutics, Inc.

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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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