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FDA 510(k)

UNI-T SPINAL SYSTEM

K-Number: K013301 · 2002-02-13

ApplicantSpine Vision, Inc.
Decision Date2002-02-13
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

UNI-T SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Spine Vision, Inc.. It received FDA 510(k) clearance on 2002-02-13 under 510(k) number K013301. 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 UNI-T SPINAL SYSTEM?

UNI-T SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2002-02-13. The listed applicant is Spine Vision, Inc.. The 510(k) number is K013301.

When did UNI-T SPINAL SYSTEM receive FDA 510(k) clearance?

UNI-T SPINAL SYSTEM received FDA 510(k) clearance on 2002-02-13, under 510(k) number K013301.

Who is the listed applicant for UNI-T SPINAL SYSTEM?

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

What is the FDA product code for UNI-T SPINAL SYSTEM?

The FDA product code for UNI-T SPINAL SYSTEM is MNI.

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Other records listing Spine Vision, Inc. as applicant

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.

K052406UNI-THREAD SPINAL SYSTEMK030526PEDIGUARD NERVE DETECTOR SYSTEMK042930SPACEVISION CAGE SYSTEMK042640UNI-THREAD SPINAL SYSTEMK033508PLUS PIVOT LINK UNIVERSAL SYSTEMK032398PLUS PIVOT LINK UNIVERSAL SYSTEM

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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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