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FDA 510(k)

BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION)

K-Number: K030581 · 2003-06-26

ApplicantBlackstone Medical, Inc.
Decision Date2003-06-26
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION) 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 2003-06-26 under 510(k) number K030581. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION)?

BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION) is a medical device that received FDA 510(k) clearance on 2003-06-26. The listed applicant is Blackstone Medical, Inc.. The 510(k) number is K030581.

When did BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION) receive FDA 510(k) clearance?

BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION) received FDA 510(k) clearance on 2003-06-26, under 510(k) number K030581.

Who is the listed applicant for BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION)?

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 LATERAL OFFSET (SYSTEM MODIFICATION)?

The FDA product code for BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION) is MNH. This falls under the ENT category.

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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: MNH)

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.

K162066Reliance Spinal Screw SystemReliance Medical Systems, LLCK162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd.K162143FixxSure® X-LinkInnovasis, Inc.K161151Spinal fixation systemCanwell Medical Co., Ltd.K162189ANAX™ 5.5 Spinal SystemU&I CorporationK151362HC Spinal SystemHung Chun Bio-S 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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