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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 K131296
Device Name VARILIFT-L INTERBODY FUSION DEVICE
Applicant
Wenzel Spine, Inc.
206 Wild Basin Rd.
Bldg. A, Suite 203
Austin,  TX  78746
Applicant Contact SANDIE ROTH
Correspondent
Wenzel Spine, Inc.
206 Wild Basin Rd.
Bldg. A, Suite 203
Austin,  TX  78746
Correspondent Contact SANDIE ROTH
Regulation Number888.3080
Classification Product Code
MAX  
Date Received05/06/2013
Decision Date 09/03/2013
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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