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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 K141443
Device Name INFRONT LUMBAR INTERBODY FUSION SYSTEM
Applicant
Infront Medical, LLC
1033 Us Hwy. 46 E.,
Suite A202
Clifton,  NJ  07013
Applicant Contact JOHN KUCZYNSKI
Correspondent
Infront Medical, LLC
1033 Us Hwy. 46 E.,
Suite A202
Clifton,  NJ  07013
Correspondent Contact JOHN KUCZYNSKI
Regulation Number888.3080
Classification Product Code
MAX  
Date Received06/02/2014
Decision Date 08/28/2014
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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