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FDA 510(k)

SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY

K-Number: K131792 · 2013-12-16

ApplicantSynthes, Inc.
Decision Date2013-12-16
Product CodeGXQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY is the device name listed in this FDA 510(k) record. The listed applicant is Synthes, Inc.. It received FDA 510(k) clearance on 2013-12-16 under 510(k) number K131792. 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 REPAIR, SYNTHECEL DURA ONLAY?

SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY is a medical device that received FDA 510(k) clearance on 2013-12-16. The listed applicant is Synthes, Inc.. The 510(k) number is K131792.

When did SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY receive FDA 510(k) clearance?

SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY received FDA 510(k) clearance on 2013-12-16, under 510(k) number K131792.

Who is the listed applicant for SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY?

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

What is the FDA product code for SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY?

The FDA product code for SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY is GXQ.

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Other records listing Synthes, Inc. as applicant

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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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