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FDA 510(k)

CERVICAL PLATE

K-Number: K042317 · 2004-09-24

ApplicantScient'X
Decision Date2004-09-24
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CERVICAL PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Scient'X. It received FDA 510(k) clearance on 2004-09-24 under 510(k) number K042317. 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 CERVICAL PLATE?

CERVICAL PLATE is a medical device that received FDA 510(k) clearance on 2004-09-24. The listed applicant is Scient'X. The 510(k) number is K042317.

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

CERVICAL PLATE received FDA 510(k) clearance on 2004-09-24, under 510(k) number K042317.

Who is the listed applicant for CERVICAL PLATE?

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

What is the FDA product code for CERVICAL PLATE?

The FDA product code for CERVICAL PLATE is KWQ.

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Other records listing Scient'X 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.

K071261ISOBAR SEMI-RIGID DUAL DAMPENERK062912SCIENT'X SPINAL SYSTEMK052763STELLA CERVICAL PLATEK052367SCIENT'X CEMENT RESTRICTORK050348CO VERTEBRAL BODY REPLACEMENTK051063POLYAXIAL HEMISPHERICAL SPINAL SCREWS

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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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