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
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