LDR SPINE SPINETUNE TL SPINAL SYSTEM

Orthosis, Spondylolisthesis Spinal Fixation

LDR SPINE USA INC.

The following data is part of a premarket notification filed by Ldr Spine Usa Inc. with the FDA for Ldr Spine Spinetune Tl Spinal System.

Pre-market Notification Details

Device IDK120760
510k NumberK120760
Device Name:LDR SPINE SPINETUNE TL SPINAL SYSTEM
ClassificationOrthosis, Spondylolisthesis Spinal Fixation
Applicant LDR SPINE USA INC. 13785 RESEARCH BOULEVARD SUITE 200 Austin,  TX  78750
ContactKiersten Soderman
CorrespondentKiersten Soderman
LDR SPINE USA INC. 13785 RESEARCH BOULEVARD SUITE 200 Austin,  TX  78750
Product CodeMNH  
Subsequent Product CodeKWP
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-03-13
Decision Date2012-06-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03662663007870 K120760 000
03662663006972 K120760 000
03662663006965 K120760 000
03662663006958 K120760 000
03662663006941 K120760 000
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03662663006927 K120760 000
03662663006910 K120760 000
03662663006903 K120760 000
03662663006897 K120760 000
03662663006989 K120760 000
03662663006996 K120760 000
03662663007863 K120760 000
03662663007856 K120760 000
03662663007061 K120760 000
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03662663007030 K120760 000
03662663007023 K120760 000
03662663007016 K120760 000
03662663007009 K120760 000
03662663006880 K120760 000

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