S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM

Intervertebral Fusion Device With Integrated Fixation, Lumbar

Renovis Surgical Technologies, Inc.

The following data is part of a premarket notification filed by Renovis Surgical Technologies, Inc. with the FDA for S128 Anterior Lumbar Interbody Fusion (alif) System.

Pre-market Notification Details

Device IDK140106
510k NumberK140106
Device Name:S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
ClassificationIntervertebral Fusion Device With Integrated Fixation, Lumbar
Applicant Renovis Surgical Technologies, Inc. 200 HOMER AVE. Ashland,  MA  01721
ContactSharyn Orton
CorrespondentSharyn Orton
Renovis Surgical Technologies, Inc. 200 HOMER AVE. Ashland,  MA  01721
Product CodeOVD  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-01-15
Decision Date2014-03-27
Summary:summary

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