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FDA 510(k)

Surgimatix Absorbable Fixation System

K-Number: K201934 · 2021-10-01

ApplicantSurgimatix, Inc.
Decision Date2021-10-01
Product CodeGDW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Surgimatix Absorbable Fixation System is a medical device manufactured by Surgimatix, Inc.. It received FDA 510(k) clearance on 2021-10-01 under approval number K201934. 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 Surgimatix Absorbable Fixation System?

Surgimatix Absorbable Fixation System is a medical device that received FDA 510(k) clearance on 2021-10-01. It is manufactured by Surgimatix, Inc.. The 510(k) number is K201934.

When was Surgimatix Absorbable Fixation System approved by the FDA?

Surgimatix Absorbable Fixation System received FDA 510(k) clearance on 2021-10-01, under approval number K201934.

What company makes Surgimatix Absorbable Fixation System?

Surgimatix Absorbable Fixation System is manufactured by Surgimatix, Inc..

What is the FDA product code for Surgimatix Absorbable Fixation System?

The FDA product code for Surgimatix Absorbable Fixation System is GDW.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07245719 Stryker Universal Midface and Upper-Face Fixation System: A Retrospective Post Market Follow Up COMPLETED NCT07485829 Zimmer Biomet-RibFix Titan RECRUITING NCT07529028 Safety and Efficacy of the AbsnowTM II Absorbable Atrial Septal Defect Closure System for Atrial Septal Defect Closure Therapy NOT_YET_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)

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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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