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FDA 510(k)

SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM

K-Number: K123723 · 2013-09-05

ApplicantSynthes
Decision Date2013-09-05
Product CodeGWO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Synthes. It received FDA 510(k) clearance on 2013-09-05 under 510(k) number K123723. The device is classified under product code GWO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM?

SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM is a medical device that received FDA 510(k) clearance on 2013-09-05. The listed applicant is Synthes. The 510(k) number is K123723.

When did SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM receive FDA 510(k) clearance?

SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM received FDA 510(k) clearance on 2013-09-05, under 510(k) number K123723.

Who is the listed applicant for SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM?

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 SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM?

The FDA product code for SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM is GWO.

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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.

K122455SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEMK113071SYNTHECEL DURA REPLACEMENT DEVICESK110604VBB SYSTEMK093772SYNTHES STERNAL FIXATION SYSTEMK013072CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP)K020602SYNTHES PILON PLATE

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Related Devices (Code: GWO)

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.

K262874CraniUS PlateCraniUS, LLCK261058CraniUS PlateCraniUS, LLCK250297TECHFIT Patient-Specific Cranial SystemTechfit Digital Surgery, Inc.K250334Fusion Craniofacial Implant; Fusion Skull ImplantKelyniam Global, Inc.K231834VSP PEEK Cranial Implant3D Systems, Inc.K212391MCI-Neuro Fixation SystemMci Medical Concept Innovation, 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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