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FDA 510(k)

ANTERIOR DISTRACTION SYSTEM

K-Number: K820034 · 1982-03-11

ApplicantStuart
Decision Date1982-03-11
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ANTERIOR DISTRACTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Stuart. It received FDA 510(k) clearance on 1982-03-11 under 510(k) number K820034. 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 ANTERIOR DISTRACTION SYSTEM?

ANTERIOR DISTRACTION SYSTEM is a medical device that received FDA 510(k) clearance on 1982-03-11. The listed applicant is Stuart. The 510(k) number is K820034.

When did ANTERIOR DISTRACTION SYSTEM receive FDA 510(k) clearance?

ANTERIOR DISTRACTION SYSTEM received FDA 510(k) clearance on 1982-03-11, under 510(k) number K820034.

Who is the listed applicant for ANTERIOR DISTRACTION SYSTEM?

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

What is the FDA product code for ANTERIOR DISTRACTION SYSTEM?

The FDA product code for ANTERIOR DISTRACTION SYSTEM is KWQ.

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Other records listing Stuart 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.

K897141SLOT STAPLES AND ADAPTOR FOR ZIELKE SPINAL FIXATIOK890601STUART TITANIUM SURGICAL MESHK851414SEGMENTAL SPINAL RODSK843445SACRAL BAR

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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