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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 K112316
FOIA Releasable 510(k) K112316
Device Name 4-WEB ALIF SPINAL TRUSS SYSTEM (STS)
Applicant
4-Web, Inc.
13540 Guild Ave.
Apple Valley,  MN  55124
Applicant Contact RICH JANSEN, PHARM. D.
Correspondent
4-Web, Inc.
13540 Guild Ave.
Apple Valley,  MN  55124
Correspondent Contact RICH JANSEN, PHARM. D.
Regulation Number888.3080
Classification Product Code
MAX  
Date Received08/11/2011
Decision Date 12/14/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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