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FDA 510(k)

PLUS PIVOT LINK UNIVERSAL SYSTEM

K-Number: K032398 · 2003-10-31

ApplicantSpine Vision, Inc.
Decision Date2003-10-31
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PLUS PIVOT LINK UNIVERSAL 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 2003-10-31 under 510(k) number K032398. 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 PLUS PIVOT LINK UNIVERSAL SYSTEM?

PLUS PIVOT LINK UNIVERSAL SYSTEM is a medical device that received FDA 510(k) clearance on 2003-10-31. The listed applicant is Spine Vision, Inc.. The 510(k) number is K032398.

When did PLUS PIVOT LINK UNIVERSAL SYSTEM receive FDA 510(k) clearance?

PLUS PIVOT LINK UNIVERSAL SYSTEM received FDA 510(k) clearance on 2003-10-31, under 510(k) number K032398.

Who is the listed applicant for PLUS PIVOT LINK UNIVERSAL 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 PLUS PIVOT LINK UNIVERSAL SYSTEM?

The FDA product code for PLUS PIVOT LINK UNIVERSAL 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 SYSTEMK022271PLUS 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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