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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Lumbar
510(k) Number K160076
Device Name XCage™ Interbody Fusion System
Applicant
Ouroboros Medical, Inc.
47757 Fremont Blvd.
Fremont,  CA  94538
Applicant Contact John To
Correspondent
Ouroboros Medical, Inc.
47757 Fremont Blvd.
Fremont,  CA  94538
Correspondent Contact John To
Regulation Number888.3080
Classification Product Code
MAX  
Date Received01/14/2016
Decision Date 10/13/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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