ROI IR935R

GUDID 03662663042499

LDR Spine Usa, Inc.

Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable

• Primary Device ID: 03662663042499
• NIH Device Record Key: 446de7a3-cb92-4983-845a-5370333292b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROI
• Version Model Number: IR935R
• Catalog Number: IR935R
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03662663042499 [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

[03662663042499]

Moist Heat or Steam Sterilization

[03662663042499]

Moist Heat or Steam Sterilization

[03662663042499]

Moist Heat or Steam Sterilization

[03662663042499]

Moist Heat or Steam Sterilization

[03662663042499]

Moist Heat or Steam Sterilization

[03662663042499]

Moist Heat or Steam Sterilization

[03662663042499]

Moist Heat or Steam Sterilization

[03662663042499]

Moist Heat or Steam Sterilization

[03662663042499]

Moist Heat or Steam Sterilization

[03662663042499]

Moist Heat or Steam Sterilization

[03662663042499]

Moist Heat or Steam Sterilization

[03662663042499]

Moist Heat or Steam Sterilization

[03662663042499]

Moist Heat or Steam Sterilization

[03662663042499]

Moist Heat or Steam Sterilization

[03662663042499]

Moist Heat or Steam Sterilization

[03662663042499]

Moist Heat or Steam Sterilization

[03662663042499]

Moist Heat or Steam Sterilization

[03662663042499]

Moist Heat or Steam Sterilization

[03662663042499]

Moist Heat or Steam Sterilization

[03662663042499]

Moist Heat or Steam Sterilization

[03662663042499]

Moist Heat or Steam Sterilization

[03662663042499]

Moist Heat or Steam Sterilization

[03662663042499]

Moist Heat or Steam Sterilization

[03662663042499]

Moist Heat or Steam Sterilization

[03662663042499]

Moist Heat or Steam Sterilization

[03662663042499]

Moist Heat or Steam Sterilization

[03662663042499]

Moist Heat or Steam Sterilization

[03662663042499]

Moist Heat or Steam Sterilization

[03662663042499]

Moist Heat or Steam Sterilization

[03662663042499]

Moist Heat or Steam Sterilization

[03662663042499]

Moist Heat or Steam Sterilization

[03662663042499]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-05-07
• 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