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FDA 510(k)

MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM

K-Number: K051815 · 2005-10-17

ApplicantVertebron, Inc.
Decision Date2005-10-17
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Vertebron, Inc.. It received FDA 510(k) clearance on 2005-10-17 under 510(k) number K051815. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM?

MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 2005-10-17. The listed applicant is Vertebron, Inc.. The 510(k) number is K051815.

When did MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM received FDA 510(k) clearance on 2005-10-17, under 510(k) number K051815.

Who is the listed applicant for MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM?

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

What is the FDA product code for MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM?

The FDA product code for MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM is KWQ.

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Other records listing Vertebron, 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.

K081567VERTEBRON SSP CERVICAL PLATING SYSTEMK081597MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEMK073502VERTEBRON VBR SYSTEMK071376MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEMK062110VERTEBRON SCP CERVICAL PLATE SYSTEMK051716VERTEBRON PSS PEDICLE SCREW SYSTEM

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Related Devices (Code: KWQ)

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.

K262149corra® cervical plating systemCarlsmed, Inc.K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLCK252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLC

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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