GII SPINAL FIXATION SYSTEM

Orthosis, Spondylolisthesis Spinal Fixation

CO-LIGNE AG

The following data is part of a premarket notification filed by Co-ligne Ag with the FDA for Gii Spinal Fixation System.

Pre-market Notification Details

• Device ID: K032604
• 510k Number: K032604
• Device Name: GII SPINAL FIXATION SYSTEM
• Classification: Orthosis, Spondylolisthesis Spinal Fixation
• Applicant: CO-LIGNE AG 9260 VIAU BLVD. Montreal, CA H1r 2v8
• Contact: Ariel Dujovne, Ing. M.sc.
• Correspondent: Ariel Dujovne, Ing. M.sc.; CO-LIGNE AG 9260 VIAU BLVD. Montreal, CA H1r 2v8
• Product Code: MNH
• Subsequent Product Code: KWP
• Subsequent Product Code: MNI
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-08-25
• Decision Date: 2004-01-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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