Karma® Fixation System

Bone Fixation Cerclage, Sublaminar

Spinal Elements Inc

The following data is part of a premarket notification filed by Spinal Elements Inc with the FDA for Karma® Fixation System.

Pre-market Notification Details

• Device ID: K190289
• 510k Number: K190289
• Device Name: Karma® Fixation System
• Classification: Bone Fixation Cerclage, Sublaminar
• Applicant: Spinal Elements Inc 3115 Melrose Dr., Suite 200 Carlsbad, CA 92010
• Contact: Julie Lamothe
• Correspondent: Julie Lamothe; Spinal Elements Inc 3115 Melrose Dr., Suite 200 Carlsbad, CA 92010
• Product Code: OWI
• CFR Regulation Number: 888.3010 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-02-11
• Decision Date: 2019-04-03

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840606167956	K190289	000