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FDA 510(k)

SONOMA ANTERIOR CERVICAL PLATE SYSTEM

K-Number: K032368 · 2003-10-09

ApplicantSeaspine
Decision Date2003-10-09
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SONOMA ANTERIOR CERVICAL PLATE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Seaspine. It received FDA 510(k) clearance on 2003-10-09 under 510(k) number K032368. 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 SONOMA ANTERIOR CERVICAL PLATE SYSTEM?

SONOMA ANTERIOR CERVICAL PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 2003-10-09. The listed applicant is Seaspine. The 510(k) number is K032368.

When did SONOMA ANTERIOR CERVICAL PLATE SYSTEM receive FDA 510(k) clearance?

SONOMA ANTERIOR CERVICAL PLATE SYSTEM received FDA 510(k) clearance on 2003-10-09, under 510(k) number K032368.

Who is the listed applicant for SONOMA ANTERIOR CERVICAL PLATE SYSTEM?

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

What is the FDA product code for SONOMA ANTERIOR CERVICAL PLATE SYSTEM?

The FDA product code for SONOMA ANTERIOR CERVICAL PLATE SYSTEM is KWQ.

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Other records listing Seaspine 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.

K043232UCR SPINAL SYSTEMK040130ANTERIOR LUMBAR BUTTRESS SYSTEMK032739UCR SPINAL SYSTEMK031381UCR SPINAL SYSTEM, LAMINAR HOOKS, PEDICLE HOOKS, AND INSTRUMENTS

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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