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FDA 510(k)

GII SPINAL FIXATION SYSTEM, GII-TI-POLY AXIAL SCREW

K-Number: K083567 · 2009-09-14

ApplicantCo-Ligne AG
Decision Date2009-09-14
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GII SPINAL FIXATION SYSTEM, GII-TI-POLY AXIAL SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Co-Ligne AG. It received FDA 510(k) clearance on 2009-09-14 under 510(k) number K083567. 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 GII SPINAL FIXATION SYSTEM, GII-TI-POLY AXIAL SCREW?

GII SPINAL FIXATION SYSTEM, GII-TI-POLY AXIAL SCREW is a medical device that received FDA 510(k) clearance on 2009-09-14. The listed applicant is Co-Ligne AG. The 510(k) number is K083567.

When did GII SPINAL FIXATION SYSTEM, GII-TI-POLY AXIAL SCREW receive FDA 510(k) clearance?

GII SPINAL FIXATION SYSTEM, GII-TI-POLY AXIAL SCREW received FDA 510(k) clearance on 2009-09-14, under 510(k) number K083567.

Who is the listed applicant for GII SPINAL FIXATION SYSTEM, GII-TI-POLY AXIAL SCREW?

The FDA 510(k) record lists Co-Ligne AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GII SPINAL FIXATION SYSTEM, GII-TI-POLY AXIAL SCREW?

The FDA product code for GII SPINAL FIXATION SYSTEM, GII-TI-POLY AXIAL SCREW is MNH. This falls under the ENT category.

Related Clinical Trials

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.

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Other records listing Co-Ligne AG 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.

K072326OSTAPEK VBR SYSTEMK051089GII SPINAL FIXATION SYSTEMK032604GII SPINAL FIXATION SYSTEM

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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