SpineTune TL

GUDID 03662663007870

CURVED ROD 6.0 L130 MM

LDR Spine Usa, Inc.

Bone-screw internal spinal fixation system, sterile
Primary Device ID03662663007870
NIH Device Record Keyd17d38fa-8672-4ffb-ba55-d8a8f64d20a9
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpineTune TL
Version Model NumberST5513T-S
Company DUNS615789729
Company NameLDR Spine Usa, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone512-344-3333
Emailsurgeoninfo@ldrspine.com
Phone512-344-3333
Emailsurgeoninfo@ldrspine.com
Phone512-344-3333
Emailsurgeoninfo@ldrspine.com
Phone512-344-3333
Emailsurgeoninfo@ldrspine.com
Phone512-344-3333
Emailsurgeoninfo@ldrspine.com
Phone512-344-3333
Emailsurgeoninfo@ldrspine.com
Phone512-344-3333
Emailsurgeoninfo@ldrspine.com
Phone512-344-3333
Emailsurgeoninfo@ldrspine.com
Phone512-344-3333
Emailsurgeoninfo@ldrspine.com
Phone512-344-3333
Emailsurgeoninfo@ldrspine.com
Phone512-344-3333
Emailsurgeoninfo@ldrspine.com
Phone512-344-3333
Emailsurgeoninfo@ldrspine.com
Phone512-344-3333
Emailsurgeoninfo@ldrspine.com
Phone512-344-3333
Emailsurgeoninfo@ldrspine.com
Phone512-344-3333
Emailsurgeoninfo@ldrspine.com
Phone512-344-3333
Emailsurgeoninfo@ldrspine.com
Phone512-344-3333
Emailsurgeoninfo@ldrspine.com
Phone512-344-3333
Emailsurgeoninfo@ldrspine.com
Phone512-344-3333
Emailsurgeoninfo@ldrspine.com
Phone512-344-3333
Emailsurgeoninfo@ldrspine.com
Phone512-344-3333
Emailsurgeoninfo@ldrspine.com
Phone512-344-3333
Emailsurgeoninfo@ldrspine.com
Phone512-344-3333
Emailsurgeoninfo@ldrspine.com
Phone512-344-3333
Emailsurgeoninfo@ldrspine.com
Phone512-344-3333
Emailsurgeoninfo@ldrspine.com
Phone512-344-3333
Emailsurgeoninfo@ldrspine.com
Phone512-344-3333
Emailsurgeoninfo@ldrspine.com
Phone512-344-3333
Emailsurgeoninfo@ldrspine.com
Phone512-344-3333
Emailsurgeoninfo@ldrspine.com
Phone512-344-3333
Emailsurgeoninfo@ldrspine.com
Phone512-344-3333
Emailsurgeoninfo@ldrspine.com
Phone512-344-3333
Emailsurgeoninfo@ldrspine.com
Phone512-344-3333
Emailsurgeoninfo@ldrspine.com
Phone512-344-3333
Emailsurgeoninfo@ldrspine.com
Phone512-344-3333
Emailsurgeoninfo@ldrspine.com
Phone512-344-3333
Emailsurgeoninfo@ldrspine.com
Phone512-344-3333
Emailsurgeoninfo@ldrspine.com
Phone512-344-3333
Emailsurgeoninfo@ldrspine.com
Phone512-344-3333
Emailsurgeoninfo@ldrspine.com
Phone512-344-3333
Emailsurgeoninfo@ldrspine.com
Phone512-344-3333
Emailsurgeoninfo@ldrspine.com
Phone512-344-3333
Emailsurgeoninfo@ldrspine.com
Phone512-344-3333
Emailsurgeoninfo@ldrspine.com

Device Dimensions

Length130 Millimeter
Outer Diameter6 Millimeter
Length130 Millimeter
Outer Diameter6 Millimeter
Length130 Millimeter
Outer Diameter6 Millimeter
Length130 Millimeter
Outer Diameter6 Millimeter
Length130 Millimeter
Outer Diameter6 Millimeter
Length130 Millimeter
Outer Diameter6 Millimeter
Length130 Millimeter
Outer Diameter6 Millimeter
Length130 Millimeter
Outer Diameter6 Millimeter
Length130 Millimeter
Outer Diameter6 Millimeter
Length130 Millimeter
Outer Diameter6 Millimeter
Length130 Millimeter
Outer Diameter6 Millimeter
Length130 Millimeter
Outer Diameter6 Millimeter
Length130 Millimeter
Outer Diameter6 Millimeter
Length130 Millimeter
Outer Diameter6 Millimeter
Length130 Millimeter
Outer Diameter6 Millimeter
Length130 Millimeter
Outer Diameter6 Millimeter
Length130 Millimeter
Outer Diameter6 Millimeter
Length130 Millimeter
Outer Diameter6 Millimeter
Length130 Millimeter
Outer Diameter6 Millimeter
Length130 Millimeter
Outer Diameter6 Millimeter
Length130 Millimeter
Outer Diameter6 Millimeter
Length130 Millimeter
Outer Diameter6 Millimeter
Length130 Millimeter
Outer Diameter6 Millimeter
Length130 Millimeter
Outer Diameter6 Millimeter
Length130 Millimeter
Outer Diameter6 Millimeter
Length130 Millimeter
Outer Diameter6 Millimeter
Length130 Millimeter
Outer Diameter6 Millimeter
Length130 Millimeter
Outer Diameter6 Millimeter
Length130 Millimeter
Outer Diameter6 Millimeter
Length130 Millimeter
Outer Diameter6 Millimeter
Length130 Millimeter
Outer Diameter6 Millimeter
Length130 Millimeter
Outer Diameter6 Millimeter
Length130 Millimeter
Outer Diameter6 Millimeter
Length130 Millimeter
Outer Diameter6 Millimeter
Length130 Millimeter
Outer Diameter6 Millimeter
Length130 Millimeter
Outer Diameter6 Millimeter
Length130 Millimeter
Outer Diameter6 Millimeter
Length130 Millimeter
Outer Diameter6 Millimeter
Length130 Millimeter
Outer Diameter6 Millimeter
Length130 Millimeter
Outer Diameter6 Millimeter
Length130 Millimeter
Outer Diameter6 Millimeter
Length130 Millimeter
Outer Diameter6 Millimeter
Length130 Millimeter
Outer Diameter6 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS103662663007870 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNIOrthosis, Spinal Pedicle Fixation

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-03-10
Device Publish Date2015-10-24

On-Brand Devices [SpineTune TL]

03662663045469ST9064R
03662663045445ST9062R
03662663045407ST9058R
03662663045391ST9057R
03662663045377ST9052R
03662663045360ST9051R
03662663045193ST9034R
03662663045186ST9033R
03662663045131ST9028R
03662663044981ST9013R
03662663044974ST9012R
03662663044967ST9011R
03662663044950ST9010R
03662663044943ST9009R
03662663044912ST9006R
03662663044905ST9005R
03662663046114ST9904
03662663046107ST9903B
03662663046091ST9903A
03662663045551ST9056R
03662663045544ST9055R
03662663045537ST9053R
03662663045483ST9066R
03662663045476ST9065R
03662663045452ST9063R
03662663045438ST9061R
03662663045421ST9060R
03662663045414ST9059R
03662663045384ST9054R
03662663045353ST9050R
03662663045346ST9049R
03662663045339ST9048R
03662663045322ST9047R
03662663045315ST9046R
03662663045308ST9045R
03662663045292ST9044R
03662663045285ST9043R
03662663045278ST9042R
03662663045261ST9041R
03662663045254ST9040R
03662663045247ST9039R
03662663045230ST9038R
03662663045223ST9037R
03662663045216ST9036R
03662663045209ST9035R
03662663045179ST9032R
03662663045162ST9031R
03662663045155ST9030R
03662663045148ST9029R
03662663045124ST9027R

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