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FDA 510(k)

RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM

K-Number: K130309 · 2013-06-17

ApplicantBiomet Microfixation
Decision Date2013-06-17
Product CodeGXR
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Microfixation. It received FDA 510(k) clearance on 2013-06-17 under 510(k) number K130309. 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 RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM?

RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2013-06-17. The listed applicant is Biomet Microfixation. The 510(k) number is K130309.

When did RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM receive FDA 510(k) clearance?

RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM received FDA 510(k) clearance on 2013-06-17, under 510(k) number K130309.

Who is the listed applicant for RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM?

The FDA 510(k) record lists Biomet Microfixation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM?

The FDA product code for RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM is GXR.

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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.LK221606Absorbable Cranial Flap Fixation SystemChendu Medart Medical Scientific Co., Ltd.K192310Flap Fixator, Burr Hole CoverOssaware Biotech Co., Ltd.K192162NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC PlateNeurovention, LLCK181539OSSDSIGN CranioplugOssdsign AB

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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