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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 K120603
Device Name VARILIFT -C
Applicant
Wenzel Spine
206 Wild Basin Rd.
Bldg. A, Suite 203
Austin,  TX  78746
Applicant Contact SOURABH MISHRA
Correspondent
Wenzel Spine
206 Wild Basin Rd.
Bldg. A, Suite 203
Austin,  TX  78746
Correspondent Contact SOURABH MISHRA
Regulation Number888.3080
Classification Product Code
ODP  
Date Received02/28/2012
Decision Date 01/29/2013
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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