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FDA 510(k)

SYNTHECEL DURA REPLACEMENT DEVICES

K-Number: K113071 · 2012-01-09

ApplicantSynthes
Decision Date2012-01-09
Product CodeGXQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SYNTHECEL DURA REPLACEMENT DEVICES is the device name listed in this FDA 510(k) record. The listed applicant is Synthes. It received FDA 510(k) clearance on 2012-01-09 under 510(k) number K113071. The device is classified under product code GXQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNTHECEL DURA REPLACEMENT DEVICES?

SYNTHECEL DURA REPLACEMENT DEVICES is a medical device that received FDA 510(k) clearance on 2012-01-09. The listed applicant is Synthes. The 510(k) number is K113071.

When did SYNTHECEL DURA REPLACEMENT DEVICES receive FDA 510(k) clearance?

SYNTHECEL DURA REPLACEMENT DEVICES received FDA 510(k) clearance on 2012-01-09, under 510(k) number K113071.

Who is the listed applicant for SYNTHECEL DURA REPLACEMENT DEVICES?

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

What is the FDA product code for SYNTHECEL DURA REPLACEMENT DEVICES?

The FDA product code for SYNTHECEL DURA REPLACEMENT DEVICES is GXQ.

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Other records listing Synthes as applicant

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.

K123723SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEMK122455SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEMK110604VBB SYSTEMK093772SYNTHES STERNAL FIXATION SYSTEMK013072CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP)K020602SYNTHES PILON PLATE

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Related Devices (Code: GXQ)

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.

K251191Collagen Dura Regeneration Membrane - RepairCollagen Matrix, Inc.K250420Helios Dura Regeneration MatrixHelios Biomedical, Inc.K223445ArtiFasciaNurami Medical , Ltd.K212943SyntheCel Dura RepairSynthes (USA) Products, LLCK183513XenoSure Dura Biologic PatchLeMaitre Vascular, Inc.K172603Cerafix Dura SubstituteAcera Surgical, Inc.

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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