SPINESMITH CYNCH SPINAL SYSTEM - VISUALIF INTERBODY FUSION IMPLANT SYSTEM

Intervertebral Fusion Device With Integrated Fixation, Lumbar

SPINE SMITH PARTNERS L.P.

The following data is part of a premarket notification filed by Spine Smith Partners L.p. with the FDA for Spinesmith Cynch Spinal System - Visualif Interbody Fusion Implant System.

Pre-market Notification Details

Device IDK102090
510k NumberK102090
Device Name:SPINESMITH CYNCH SPINAL SYSTEM - VISUALIF INTERBODY FUSION IMPLANT SYSTEM
ClassificationIntervertebral Fusion Device With Integrated Fixation, Lumbar
Applicant SPINE SMITH PARTNERS L.P. 93 RED RIVER Austin,  TX  78701
ContactLaura Leboeuf
CorrespondentLaura Leboeuf
SPINE SMITH PARTNERS L.P. 93 RED RIVER Austin,  TX  78701
Product CodeOVD  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-07-26
Decision Date2010-09-30
Summary:summary

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