Gii Spinal Fixation System, Gii-Ti-Poly Axial Screw

FDA 510(k) K083567 · Co-Ligne AG

Substantially Equivalent

510(k) numberK083567

Submission

Device name
Gii Spinal Fixation System, Gii-Ti-Poly Axial Screw
Applicant
Co-Ligne AG
Concord, CA, US
Received
December 3, 2008
Decision date
September 14, 2009
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MNH – Orthosis, Spondylolisthesis Spinal Fixation
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3070
Specialty
Orthopedic
Implant
Yes

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K153404Zavation Spinal SystemMNH · Traditional Zavation, LLC04/21/2016SE
K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemMNH · Special Captiva Spine03/02/2016SE
K143013Spinal Inner Fixation SystemMNH · Traditional Changzhou Dingjian Medical Appliance Co., Ltd.12/11/2015SE
K151695Romeo posterior osteosynthesis systemMNH · Traditional Spineart09/10/2015SE

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Questions and answers

When was Gii Spinal Fixation System, Gii-Ti-Poly Axial Screw cleared by the FDA?

Gii Spinal Fixation System, Gii-Ti-Poly Axial Screw (K083567) received a 510(k) decision of Substantially Equivalent on September 14, 2009, 285 days after the submission was received.

What is the product code of K083567?

The FDA product code is MNH – Orthosis, Spondylolisthesis Spinal Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.