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FDA 510(k)

BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MONO-AXIAL SCREW

K-Number: K013558 · 2002-01-23

ApplicantBlackstone Medical, Inc.
Decision Date2002-01-23
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MONO-AXIAL SCREW 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 2002-01-23 under 510(k) number K013558. 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 SPINAL FIXATION SYSTEM 4.5MM MONO-AXIAL SCREW?

BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MONO-AXIAL SCREW is a medical device that received FDA 510(k) clearance on 2002-01-23. The listed applicant is Blackstone Medical, Inc.. The 510(k) number is K013558.

When did BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MONO-AXIAL SCREW receive FDA 510(k) clearance?

BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MONO-AXIAL SCREW received FDA 510(k) clearance on 2002-01-23, under 510(k) number K013558.

Who is the listed applicant for BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MONO-AXIAL SCREW?

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 4.5MM MONO-AXIAL SCREW?

The FDA product code for BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MONO-AXIAL SCREW is KWQ.

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Other records listing Blackstone Medical, Inc. as applicant

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Related Devices (Code: KWQ)

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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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