ROI IR901R

GUDID 03662663040587

LDR Spine Usa, Inc.

Bone lever/elevator

• Primary Device ID: 03662663040587
• NIH Device Record Key: 6ea563e5-7661-478d-af40-9f07ef37968d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROI
• Version Model Number: IR901R
• Catalog Number: IR901R
• 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

Device Dimensions

• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
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• Height: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	03662663040587 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121103

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

[03662663040587]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-03-10
• Device Publish Date: 2018-12-11

On-Brand Devices [ROI]

• 03662663042499: IR935R
• 03662663043151: IR946R
• 03662663043144: IR945R
• 03662663042710: IR937R
• 03662663042604: IR936R
• 03662663041577: IR913R
• 03662663041492: IR912R
• 03662663046060: IR990
• 03662663043137: TRIAL IMPLANT 8° H14mm
• 03662663043120: TRIAL IMPLANT 8° H12mm
• 03662663043052: TRIAL IMPLANT 8° H10mm
• 03662663043045: TRIAL IMPLANT 5° H12mm
• 03662663043038: TRIAL IMPLANT 5° H10mm
• 03662663042932: TRIAL IMPLANT 0° H12mm
• 03662663042826: TRIAL IMPLANT 0° H10mm
• 03662663042383: TRIAL IMPLANT 8° H13mm
• 03662663042277: TRIAL IMPLANT 8° H11mm
• 03662663042161: TRIAL IMPLANT 8° H09mm
• 03662663042055: TRIAL IMPLANT 5° H13mm
• 03662663042024: TRIAL IMPLANT 5° H11mm
• 03662663041928: TRIAL IMPLANT 5° H09mm
• 03662663041812: TRIAL IMPLANT 0° H13mm
• 03662663041751: TRIAL IMPLANT 0° H11mm
• 03662663041744: TRIAL IMPLANT 0° H09mm
• 03662663041737: TRIAL IMPLANT 0° H07mm
• 03662663041720: IR923R
• 03662663041713: IR921R
• 03662663041669: IR919R
• 03662663041652: IR918R
• 03662663041645: IR917R
• 03662663041638: IR915R
• 03662663041621: IR914R
• 03662663041348: IR907R
• 03662663041331: IR906R
• 03662663041225: IR905R
• 03662663041171: IR904R
• 03662663040716: IR903R
• 03662663040686: IR902R
• 03662663040587: IR901R
• 03662663040228: IR900R
• 03662663016049: ROI V.B.R.8° L24 H13
• 03662663016032: ROI V.B.R.8° L24 H11
• 03662663016025: ROI V.B.R.8° L24 H09
• 03662663016018: ROI V.B.R.5° L24 H13
• 03662663016001: ROI V.B.R.5° L24 H11
• 03662663015998: ROI V.B.R.5° L24 H09
• 03662663015981: ROI V.B.R.0° L24 H11
• 03662663015974: ROI V.B.R.0° L24 H09
• 03662663015967: ROI VBR. 0° L24 H07
• 03662663015943: ROI POSTERIOR CAGE 8° L24mm H13mm