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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 K133529
Device Name CAMBER SPINE COVERIS CERVICAL CAGE
Applicant
Camber Spine
90 S. Newtown St. Rd.
Suite 10
Newtown Square,  PA  19073
Applicant Contact DANIEL A PONTECORVO
Correspondent
Camber Spine
90 S. Newtown St. Rd.
Suite 10
Newtown Square,  PA  19073
Correspondent Contact DANIEL A PONTECORVO
Regulation Number888.3080
Classification Product Code
ODP  
Date Received11/15/2013
Decision Date 03/20/2014
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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