CHAMELEON FIXATION SYSTEM

System, Facet Screw Spinal Device

SPINEFRONTIER, INC.

The following data is part of a premarket notification filed by Spinefrontier, Inc. with the FDA for Chameleon Fixation System.

Pre-market Notification Details

• Device ID: K071420
• 510k Number: K071420
• Device Name: CHAMELEON FIXATION SYSTEM
• Classification: System, Facet Screw Spinal Device
• Applicant: SPINEFRONTIER, INC. 100 CUMMINGS CENTER SUITE 240C Beverly, MA 01915
• Contact: Thomas Carlson
• Correspondent: Thomas Carlson; SPINEFRONTIER, INC. 100 CUMMINGS CENTER SUITE 240C Beverly, MA 01915
• Product Code: MRW
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-05-22
• Decision Date: 2008-01-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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