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FDA 510(k)

BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER)

K-Number: K020600 · 2002-05-22

ApplicantBlackstone Medical, Inc.
Decision Date2002-05-22
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER) is the device name listed in this FDA 510(k) record. The listed applicant is Blackstone Medical, Inc.. It received FDA 510(k) clearance on 2002-05-22 under 510(k) number K020600. 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 BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER)?

BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER) is a medical device that received FDA 510(k) clearance on 2002-05-22. The listed applicant is Blackstone Medical, Inc.. The 510(k) number is K020600.

When did BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER) receive FDA 510(k) clearance?

BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER) received FDA 510(k) clearance on 2002-05-22, under 510(k) number K020600.

Who is the listed applicant for BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER)?

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

What is the FDA product code for BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER)?

The FDA product code for BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER) is KWQ.

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Other records listing Blackstone Medical, Inc. as applicant

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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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