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FDA 510(k)

UNI-THREAD SPINAL SYSTEM

K-Number: K042640 · 2004-11-23

ApplicantSpine Vision, Inc.
Decision Date2004-11-23
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

UNI-THREAD 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 2004-11-23 under 510(k) number K042640. 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 UNI-THREAD SPINAL SYSTEM?

UNI-THREAD SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2004-11-23. The listed applicant is Spine Vision, Inc.. The 510(k) number is K042640.

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

UNI-THREAD SPINAL SYSTEM received FDA 510(k) clearance on 2004-11-23, under 510(k) number K042640.

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

The FDA product code for UNI-THREAD SPINAL SYSTEM is MNH. This falls under the ENT category.

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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 SYSTEMK033508PLUS PIVOT LINK UNIVERSAL SYSTEMK032398PLUS PIVOT LINK UNIVERSAL SYSTEMK022271PLUS PIVOT LINK UNIVERSAL SYSTEM

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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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