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FDA 510(k)

SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP

K-Number: K041611 · 2004-09-08

ApplicantSynthes (Usa)
Decision Date2004-09-08
Product CodeGXR
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 2004-09-08 under 510(k) number K041611. 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 SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP?

SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP is a medical device that received FDA 510(k) clearance on 2004-09-08. The listed applicant is Synthes (Usa). The 510(k) number is K041611.

When did SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP receive FDA 510(k) clearance?

SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP received FDA 510(k) clearance on 2004-09-08, under 510(k) number K041611.

Who is the listed applicant for SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP?

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

What is the FDA product code for SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP?

The FDA product code for SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP is GXR.

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Other records listing Synthes (Usa) as applicant

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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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