SpineTune TL

GUDID 03662663006941

POLYAXIAL SCREW D8.5 L40 MM

LDR Spine Usa, Inc.

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• Primary Device ID: 03662663006941
• NIH Device Record Key: 49452f35-f9be-49d4-a38d-b62aeeb2a270
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpineTune TL
• Version Model Number: ST1553T-S
• Company DUNS: 615789729
• Company Name: LDR Spine Usa, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 512-344-3333
• Email: surgeoninfo@ldrspine.com
• Phone: 512-344-3333
• Email: surgeoninfo@ldrspine.com
• Phone: 512-344-3333
• Email: surgeoninfo@ldrspine.com
• Phone: 512-344-3333
• Email: surgeoninfo@ldrspine.com
• Phone: 512-344-3333
• Email: surgeoninfo@ldrspine.com
• Phone: 512-344-3333
• Email: surgeoninfo@ldrspine.com
• Phone: 512-344-3333
• Email: surgeoninfo@ldrspine.com
• Phone: 512-344-3333
• Email: surgeoninfo@ldrspine.com
• Phone: 512-344-3333
• Email: surgeoninfo@ldrspine.com
• Phone: 512-344-3333
• Email: surgeoninfo@ldrspine.com
• Phone: 512-344-3333
• Email: surgeoninfo@ldrspine.com
• Phone: 512-344-3333
• Email: surgeoninfo@ldrspine.com
• Phone: 512-344-3333
• Email: surgeoninfo@ldrspine.com
• Phone: 512-344-3333
• Email: surgeoninfo@ldrspine.com
• Phone: 512-344-3333
• Email: surgeoninfo@ldrspine.com
• Phone: 512-344-3333
• Email: surgeoninfo@ldrspine.com
• Phone: 512-344-3333
• Email: surgeoninfo@ldrspine.com
• Phone: 512-344-3333
• Email: surgeoninfo@ldrspine.com
• Phone: 512-344-3333
• Email: surgeoninfo@ldrspine.com
• Phone: 512-344-3333
• Email: surgeoninfo@ldrspine.com
• Phone: 512-344-3333
• Email: surgeoninfo@ldrspine.com
• Phone: 512-344-3333
• Email: surgeoninfo@ldrspine.com
• Phone: 512-344-3333
• Email: surgeoninfo@ldrspine.com
• Phone: 512-344-3333
• Email: surgeoninfo@ldrspine.com
• Phone: 512-344-3333
• Email: surgeoninfo@ldrspine.com
• Phone: 512-344-3333
• Email: surgeoninfo@ldrspine.com
• Phone: 512-344-3333
• Email: surgeoninfo@ldrspine.com
• Phone: 512-344-3333
• Email: surgeoninfo@ldrspine.com
• Phone: 512-344-3333
• Email: surgeoninfo@ldrspine.com
• Phone: 512-344-3333
• Email: surgeoninfo@ldrspine.com
• Phone: 512-344-3333
• Email: surgeoninfo@ldrspine.com

Device Dimensions

• Length: 40 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	03662663006941 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120760

FDA Product Code

• MNI: Orthosis, Spinal Pedicle Fixation

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-03-10
• Device Publish Date: 2015-10-24

On-Brand Devices [SpineTune TL]

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