LDR SPINE USA SPINETUNE TL SPINAL SYSTEM

Orthosis, Spinal Pedicle Fixation

LDR SPINE USA

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

Pre-market Notification Details

Device IDK102331
510k NumberK102331
Device Name:LDR SPINE USA SPINETUNE TL SPINAL SYSTEM
ClassificationOrthosis, Spinal Pedicle Fixation
Applicant LDR SPINE USA 4030 WEST BRAKER LANE SUITE 360 Austin,  TX  78759
ContactBeckinam Nowatzke
CorrespondentBeckinam Nowatzke
LDR SPINE USA 4030 WEST BRAKER LANE SUITE 360 Austin,  TX  78759
Product CodeMNI  
Subsequent Product CodeKWP
Subsequent Product CodeMNH
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-08-17
Decision Date2010-10-15
Summary:summary

NIH GUDID Devices

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