XCage™ Interbody Fusion System

Intervertebral Fusion Device With Bone Graft, Lumbar

Ouroboros Medical, Inc.

The following data is part of a premarket notification filed by Ouroboros Medical, Inc. with the FDA for Xcage™ Interbody Fusion System.

Pre-market Notification Details

• Device ID: K160076
• 510k Number: K160076
• Device Name: XCage™ Interbody Fusion System
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: Ouroboros Medical, Inc. 47757 Fremont Blvd Fremont, CA 94538
• Contact: John To
• Correspondent: John To; Ouroboros Medical, Inc. 47757 Fremont Blvd Fremont, CA 94538
• Product Code: MAX
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-01-14
• Decision Date: 2016-10-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00818613020960	K160076	000
00818613020618	K160076	000
00850231007879	K160076	000
00850231007619	K160076	000
00850231007558	K160076	000
00850231007541	K160076	000
00850231007534	K160076	000
00850231007527	K160076	000
00850231007510	K160076	000
00850231007503	K160076	000
00850231007497	K160076	000
00850231007480	K160076	000
00850231007459	K160076	000
00850231007442	K160076	000
00850231007435	K160076	000
00850231007220	K160076	000
00850231007213	K160076	000
00818613020625	K160076	000
00818613020632	K160076	000
00818613020953	K160076	000
00818613020786	K160076	000
00818613020779	K160076	000
00818613020762	K160076	000
00818613020755	K160076	000
00818613020748	K160076	000
00818613020731	K160076	000
00818613020724	K160076	000
00818613020717	K160076	000
00818613020700	K160076	000
00818613020694	K160076	000
00818613020687	K160076	000
00818613020670	K160076	000
00818613020663	K160076	000
00818613020656	K160076	000
00818613020649	K160076	000
00850231007206	K160076	000