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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 K153786
Device Name PROW FUSION-V
Applicant
Nlt Spine, Ltd.
6 Yad Harutzim St.
Kfar-Saba,  IL 4464103
Applicant Contact Eti Zinger
Correspondent
Hogan Lovells US LLP
555 Thriteenth St., NW
Washington,  DC  20004
Correspondent Contact John J Smith, M.D., J.D.
Regulation Number888.3080
Classification Product Code
MAX  
Date Received12/31/2015
Decision Date 07/11/2016
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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