ROI-A IR8212R

GUDID 03662663037914

ROI-A TRIAL 23X33 H11 6°

LDR Spine Usa, Inc.

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Primary Device ID	03662663037914
NIH Device Record Key	188d0a8e-4fe5-4905-899d-2484ece3d3aa
Commercial Distribution Status	In Commercial Distribution
Brand Name	ROI-A
Version Model Number	IR8212R
Catalog Number	IR8212R
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

Device Dimensions

Depth	23 Millimeter
Width	33 Millimeter
Height	11 Millimeter
Angle	6 degree
Depth	23 Millimeter
Width	33 Millimeter
Height	11 Millimeter
Angle	6 degree
Depth	23 Millimeter
Width	33 Millimeter
Height	11 Millimeter
Angle	6 degree
Depth	23 Millimeter
Width	33 Millimeter
Height	11 Millimeter
Angle	6 degree
Depth	23 Millimeter
Width	33 Millimeter
Height	11 Millimeter
Angle	6 degree
Depth	23 Millimeter
Width	33 Millimeter
Height	11 Millimeter
Angle	6 degree
Depth	23 Millimeter
Width	33 Millimeter
Height	11 Millimeter
Angle	6 degree
Depth	23 Millimeter
Width	33 Millimeter
Height	11 Millimeter
Angle	6 degree
Depth	23 Millimeter
Width	33 Millimeter
Height	11 Millimeter
Angle	6 degree
Depth	23 Millimeter
Width	33 Millimeter
Height	11 Millimeter
Angle	6 degree
Depth	23 Millimeter
Width	33 Millimeter
Height	11 Millimeter
Angle	6 degree
Depth	23 Millimeter
Width	33 Millimeter
Height	11 Millimeter
Angle	6 degree
Depth	23 Millimeter
Width	33 Millimeter
Height	11 Millimeter
Angle	6 degree
Depth	23 Millimeter
Width	33 Millimeter
Height	11 Millimeter
Angle	6 degree
Depth	23 Millimeter
Width	33 Millimeter
Height	11 Millimeter
Angle	6 degree
Depth	23 Millimeter
Width	33 Millimeter
Height	11 Millimeter
Angle	6 degree
Depth	23 Millimeter
Width	33 Millimeter
Height	11 Millimeter
Angle	6 degree
Depth	23 Millimeter
Width	33 Millimeter
Height	11 Millimeter
Angle	6 degree
Depth	23 Millimeter
Width	33 Millimeter
Height	11 Millimeter
Angle	6 degree
Depth	23 Millimeter
Width	33 Millimeter
Height	11 Millimeter
Angle	6 degree
Depth	23 Millimeter
Width	33 Millimeter
Height	11 Millimeter
Angle	6 degree
Depth	23 Millimeter
Width	33 Millimeter
Height	11 Millimeter
Angle	6 degree
Depth	23 Millimeter
Width	33 Millimeter
Height	11 Millimeter
Angle	6 degree
Depth	23 Millimeter
Width	33 Millimeter
Height	11 Millimeter
Angle	6 degree
Depth	23 Millimeter
Width	33 Millimeter
Height	11 Millimeter
Angle	6 degree
Depth	23 Millimeter
Width	33 Millimeter
Height	11 Millimeter
Angle	6 degree
Depth	23 Millimeter
Width	33 Millimeter
Height	11 Millimeter
Angle	6 degree
Depth	23 Millimeter
Width	33 Millimeter
Height	11 Millimeter
Angle	6 degree
Depth	23 Millimeter
Width	33 Millimeter
Height	11 Millimeter
Angle	6 degree
Depth	23 Millimeter
Width	33 Millimeter
Height	11 Millimeter
Angle	6 degree
Depth	23 Millimeter
Width	33 Millimeter
Height	11 Millimeter
Angle	6 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	03662663037914 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K153495

FDA Product Code

OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar