GII Spinal Fixation System

Thoracolumbosacral Pedicle Screw System

Coligne AG

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

Pre-market Notification Details

• Device ID: K210306
• 510k Number: K210306
• Device Name: GII Spinal Fixation System
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: Coligne AG Utoquai 43 Zurich, CH 8008
• Contact: Robert B Lange
• Correspondent: J.d. Webb; The OrthoMedix Group, Inc. 4313 W. 3800, S. West Haven, UT 84401
• Product Code: NKB
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-02-03
• Decision Date: 2021-05-19

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07640173165170	K210306	000
07640173165309	K210306	000
07640173165316	K210306	000
07640173165323	K210306	000
07640173165330	K210306	000
07640173165347	K210306	000
07640173165354	K210306	000
07640173165361	K210306	000
07640173165378	K210306	000
07640173165385	K210306	000
07640173165392	K210306	000
07640173165293	K210306	000
07640173165286	K210306	000
07640173165187	K210306	000
07640173165194	K210306	000
07640173165200	K210306	000
07640173165217	K210306	000
07640173165224	K210306	000
07640173165231	K210306	000
07640173165248	K210306	000
07640173165255	K210306	000
07640173165262	K210306	000
07640173165279	K210306	000
07640173165408	K210306	000
07640173165415	K210306	000
07640173165422	K210306	000
07640173166436	K210306	000
07640173167068	K210306	000
07640173167075	K210306	000
07640173167082	K210306	000
07640173167099	K210306	000
07640173167105	K210306	000
07640173167112	K210306	000
07640173167129	K210306	000
07640173167136	K210306	000
07640173167143	K210306	000
07640173166429	K210306	000
07640173166412	K210306	000
07640173165569	K210306	000
07640173165620	K210306	000
07640173166108	K210306	000
07640173166290	K210306	000
07640173166306	K210306	000
07640173166313	K210306	000
07640173166320	K210306	000
07640173166382	K210306	000
07640173166399	K210306	000
07640173166405	K210306	000
07640173167150	K210306	000