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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 the device name listed in this FDA 510(k) record. The listed applicant is Chendu Medart Medical Scientific Co., Ltd.. It received FDA 510(k) clearance on 2023-11-21 under 510(k) 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. The listed applicant is Chendu Medart Medical Scientific Co., Ltd.. The 510(k) number is K221606.

When did Absorbable Cranial Flap Fixation System receive FDA 510(k) clearance?

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

Who is the listed applicant for Absorbable Cranial Flap Fixation System?

The FDA 510(k) record lists Chendu Medart Medical Scientific Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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 Devices (Code: GXR)

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.

K253447Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)Orthocon, Inc.K240137Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation SystemNeos Surgery S.LK192310Flap Fixator, Burr Hole CoverOssaware Biotech Co., Ltd.K192162NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC PlateNeurovention, LLCK181539OSSDSIGN CranioplugOssdsign ABK181382GuardianTM Burr Hole Cover SystemSt Jude Medical

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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