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FDA 510(k)

Absorbable Cranial Flap Fixation System

K-Number: K221606 · 2023-11-21

ApplicantChendu Medart Medical Scientific Co., Ltd.
Decision Date2023-11-21
Product CodeGXR
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Absorbable Cranial Flap Fixation System is a medical device manufactured by Chendu Medart Medical Scientific Co., Ltd.. It received FDA 510(k) clearance on 2023-11-21 under approval number K221606. The device is classified under product code GXR. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Absorbable Cranial Flap Fixation System?

Absorbable Cranial Flap Fixation System is a medical device that received FDA 510(k) clearance on 2023-11-21. It is manufactured by Chendu Medart Medical Scientific Co., Ltd.. The 510(k) number is K221606.

When was Absorbable Cranial Flap Fixation System approved by the FDA?

Absorbable Cranial Flap Fixation System received FDA 510(k) clearance on 2023-11-21, under approval number K221606.

What company makes Absorbable Cranial Flap Fixation System?

Absorbable Cranial Flap Fixation System is manufactured by Chendu Medart Medical Scientific Co., Ltd..

What is the FDA product code for Absorbable Cranial Flap Fixation System?

The FDA product code for Absorbable Cranial Flap Fixation System is GXR.

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 NCT06253858 Ultrasound (US) Guided External Ventricular Catheter Placement RECRUITING NCT04115033 Randomized Controlled Trial of CES for Fibromyalgia COMPLETED 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

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)

Related Devices (Code: GXR)

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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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