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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 K143126
Device Name Renovis S141 Lumbar Interbody Cage System
Renovis Surgical Technologies
1901 W. Lugonia Ave., Ste 340
Redlands,  CA  92374
Applicant Contact Josh Brown
Silver Pine Consulting
11821 Bramble Cove Drive
Ft. Myers,  FL  33905
Correspondent Contact Rich Jansen
Regulation Number888.3080
Classification Product Code
Date Received10/31/2014
Decision Date 02/06/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No