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FDA 510(k)

NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM

K-Number: K122049 · 2013-04-05

ApplicantKinamed, Inc.
Decision Date2013-04-05
Product CodeGWO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Kinamed, Inc.. It received FDA 510(k) clearance on 2013-04-05 under 510(k) number K122049. 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 NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM?

NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM is a medical device that received FDA 510(k) clearance on 2013-04-05. The listed applicant is Kinamed, Inc.. The 510(k) number is K122049.

When did NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM receive FDA 510(k) clearance?

NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM received FDA 510(k) clearance on 2013-04-05, under 510(k) number K122049.

Who is the listed applicant for NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM?

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

What is the FDA product code for NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM?

The FDA product code for NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM is GWO.

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Other records listing Kinamed, Inc. 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.

K072250SUPERCABLE GRIP AND PLATE SYSTEMK050897NAVIPRO SHOULDER SOFTWARE MODULEK033668NAVIPRO KNEE SOFTWARE MODULEK032950GEM INSET PATELLAR COMPONENTK030256ISO-ELASTIC CERCLAGE SYSTEMK020764NAVIPRO

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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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