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FDA 510(k)

BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM

K-Number: K012184 · 2002-01-30

ApplicantBlackstone Medical, Inc.
Decision Date2002-01-30
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM 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 2002-01-30 under 510(k) number K012184. 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?

BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM is a medical device that received FDA 510(k) clearance on 2002-01-30. The listed applicant is Blackstone Medical, Inc.. The 510(k) number is K012184.

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

BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM received FDA 510(k) clearance on 2002-01-30, under 510(k) number K012184.

Who is the listed applicant for BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM?

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?

The FDA product code for BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM is KWQ.

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Other records listing Blackstone Medical, Inc. as applicant

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K093926FIREBIRD SPINAL FIXATION SYSTEMK100614HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL CERVICAL PLATESK092624FIREBIRD SPINAL FIXATION SYSTEMK082797BLACKSTONE PEDICLE SCREW SYSTEMK081684BLACKSTONE PEDICLE SCREW SYSTEMK082235BLACKSTONE PILLAR XL PEEK SPACERS

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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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