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FDA 510(k)

SOFAMOR, LAURAIN DEWALD ANTERIOR FIXATION

K-Number: K940744 · 1996-01-30

ApplicantSofamor Co.
Decision Date1996-01-30
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

SOFAMOR, LAURAIN DEWALD ANTERIOR FIXATION is the device name listed in this FDA 510(k) record. The listed applicant is Sofamor Co.. It received FDA 510(k) clearance on 1996-01-30 under 510(k) number K940744. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the SOFAMOR, LAURAIN DEWALD ANTERIOR FIXATION?

SOFAMOR, LAURAIN DEWALD ANTERIOR FIXATION is a medical device that received FDA 510(k) clearance on 1996-01-30. The listed applicant is Sofamor Co.. The 510(k) number is K940744.

When did SOFAMOR, LAURAIN DEWALD ANTERIOR FIXATION receive FDA 510(k) clearance?

SOFAMOR, LAURAIN DEWALD ANTERIOR FIXATION received FDA 510(k) clearance on 1996-01-30, under 510(k) number K940744.

Who is the listed applicant for SOFAMOR, LAURAIN DEWALD ANTERIOR FIXATION?

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

What is the FDA product code for SOFAMOR, LAURAIN DEWALD ANTERIOR FIXATION?

The FDA product code for SOFAMOR, LAURAIN DEWALD ANTERIOR FIXATION is KWQ.

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Other records listing Sofamor Co. 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.

K945022APOFIX CERVICAL SPINE FIXATIONK934007SOFAMOR ORFIL SPINE FIXATION SYSTEMK873977NEW C-D SYSTEM FOR SPINAL SURGERYK843687ROD FOR RACHIS SURGERY

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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