ROI-T IR8613T

GUDID 03662663039192

SYMETRICAL TRIAL 0° L30 H9

LDR Spine Usa, Inc.

Spinal implant trial

• Primary Device ID: 03662663039192
• NIH Device Record Key: 25dad053-e1cf-4f4a-9a26-ef5565ad73f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROI-T
• Version Model Number: IR8613T
• Catalog Number: IR8613T
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com

Device Dimensions

• Length: 30 Millimeter
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Device Identifiers

Device Issuing Agency	Device ID
GS1	03662663039192 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153495

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

[03662663039192]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2022-03-10
• Device Publish Date: 2017-03-24

On-Brand Devices [ROI-T]

• 03662663041355: IR9081R
• 03662663041430: IR9097R
• 03662663041423: IR9096R
• 03662663041362: IR9083R
• 03662663041560: IR9139R
• 03662663041553: IR9138R
• 03662663046121: IR991
• 03662663041614: IR9145R
• 03662663041607: IR9144R
• 03662663041591: IR9141R
• 03662663041584: IR9140R
• 03662663041546: IR9134R
• 03662663041539: IR9133R
• 03662663041522: IR9132R
• 03662663041515: IR9131R
• 03662663041508: IR9130R
• 03662663041485: IR9129R
• 03662663041478: IR9128R
• 03662663041461: IR9127R
• 03662663041454: IR9126R
• 03662663041447: IR9098R
• 03662663041416: IR9095R
• 03662663041409: IR9093R
• 03662663041393: IR9091R
• 03662663041386: IR9090R
• 03662663041379: IR9089R
• 03662663041324: IR9069R
• 03662663041317: IR9068R
• 03662663041300: IR9067R
• 03662663041294: IR9066R
• 03662663041287: IR9065R
• 03662663041270: IR9064R
• 03662663041263: IR9063R
• 03662663041256: IR9062R
• 03662663041249: IR9061R
• 03662663041232: IR9060R
• 03662663041164: IR9049R
• 03662663041072: IR9048R
• 03662663040969: IR9047R
• 03662663040914: IR9046R
• 03662663040808: IR9045R
• 03662663040761: IR9044R
• 03662663040754: IR9043R
• 03662663040747: IR9042R
• 03662663040730: IR9041R
• 03662663040723: IR9040R
• 03662663040709: IR9039R
• 03662663040693: IR9038R
• 03662663040679: IR9029R
• 03662663040662: IR9028R