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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 K121254
Device Name CAMBER SPINE TECHNOLOGIES TLS 5.0 INERBODY CAGE
Applicant
Camber Spine Technologies
401 Yankee Ct.
Newtown Square,  PA  19073
Applicant Contact DAN PONTECORVO
Correspondent
Camber Spine Technologies
401 Yankee Ct.
Newtown Square,  PA  19073
Correspondent Contact DAN PONTECORVO
Regulation Number888.3080
Classification Product Code
MAX  
Date Received04/25/2012
Decision Date 01/11/2013
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
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