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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 Integrated Fixation, Lumbar
510(k) Number K140106
FOIA Releasable 510(k) K140106
Device Name S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
Applicant
Renovis Surgical Technologies, Inc.
200 Homer Ave.
Ashland,  MA  01721
Applicant Contact Sharyn Orton
Correspondent
Renovis Surgical Technologies, Inc.
200 Homer Ave.
Ashland,  MA  01721
Correspondent Contact Sharyn Orton
Regulation Number888.3080
Classification Product Code
OVD  
Date Received01/15/2014
Decision Date 03/27/2014
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
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