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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, Cervical
510(k) Number K122085
Device Name STINGRAY CERVICAL CAGE
Applicant
OMNI SURGICAL, LP DBA SPINE360
5000 Plaza on the Lake, Suite 305
Austin,  TX  78746
Applicant Contact DAVE LAMB
Correspondent
OMNI SURGICAL, LP DBA SPINE360
5000 Plaza on the Lake, Suite 305
Austin,  TX  78746
Correspondent Contact DAVE LAMB
Regulation Number888.3080
Classification Product Code
ODP  
Date Received07/16/2012
Decision Date 10/17/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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