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FDA 510(k)

BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR

K-Number: K003735 · 2001-05-08

ApplicantBlackstone Medical, Inc.
Decision Date2001-05-08
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR 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 2001-05-08 under 510(k) number K003735. The device is classified under product code MNI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR?

BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR is a medical device that received FDA 510(k) clearance on 2001-05-08. The listed applicant is Blackstone Medical, Inc.. The 510(k) number is K003735.

When did BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR receive FDA 510(k) clearance?

BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR received FDA 510(k) clearance on 2001-05-08, under 510(k) number K003735.

Who is the listed applicant for BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR?

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 SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR?

The FDA product code for BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR is MNI.

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Other records listing Blackstone Medical, Inc. as applicant

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Related Devices (Code: MNI)

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.

K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co. , Ltd.K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd.K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc.K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.K160320PremierShandong Weigao Orthopaedic Device Co., Ltd.

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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