Vusion CS Plus

GUDID 00822409025626

16 mm x 12 mm x 7 Degree Lordotic

Ortho Development Corporation

Polymeric spinal interbody fusion cage

Primary Device ID	00822409025626
NIH Device Record Key	dc7652a3-049e-4187-b0ec-6c3f8ceff7be
Commercial Distribution Discontinuation	2016-09-24
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	Vusion CS Plus
Version Model Number	159-1612-07
Company DUNS	876542390
Company Name	Ortho Development Corporation
Device Count	1
DM Exempt	true
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	true
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	+1(801)553-9991
Email	customerservice@odev.com
Phone	+1(801)553-9991
Email	customerservice@odev.com

Device Dimensions

Height	12 Millimeter
Height	12 Millimeter
Height	12 Millimeter
Height	12 Millimeter
Height	12 Millimeter
Height	12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822409025626 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K122588

FDA Product Code

ODP	Intervertebral fusion device with bone graft, cervical

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00822409025626]

Moist Heat or Steam Sterilization

[00822409025626]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2020-02-24
Device Publish Date	2015-08-31

On-Brand Devices [Vusion CS Plus]

00822409035076	14 mm x 6 mm x Parallel
00822409035069	14 mm x 5 mm x Parallel
00822409035052	12 mm x 12 mm x Parallel
00822409035045	12 mm x 11 mm x Parallel
00822409035038	12 mm x 10 mm x Parallel
00822409035021	12 mm x 9 mm x Parallel
00822409035014	12 mm x 8 mm x Parallel
00822409035007	12 mm x 7 mm x Parallel
00822409034994	12 mm x 6 mm x Parallel
00822409034987	12 mm x 5 mm x Parallel
00822409033591	16 mm x 12 mm x 7 Degree Lordotic
00822409033584	16 mm x 12 mm x Parallel
00822409033577	16 mm x 11 mm x 7 Degree Lordotic
00822409033560	16 mm x 11 mm x Parallel
00822409033553	16 mm x 10 mm x 7 Degree Lordotic
00822409033546	16 mm x 10 mm x Parallel
00822409033539	16 mm x 9 mm x 7 Degree Lordotic
00822409033522	16 mm x 9 mm x Parallel
00822409033515	16 mm x 8 mm x 7 Degree Lordotic
00822409033508	16 mm x 8 mm x Parallel
00822409033492	16 mm x 7 mm x 7 Degree Lordotic
00822409033485	16 mm x 7 mm x Parallel
00822409033478	16 mm x 6 mm x 7 Degree Lordotic
00822409033461	16 mm x 6 mm x Parallel
00822409033454	16 mm x 5 mm x 7 Degree Lordotic
00822409033447	16 mm x 5 mm x Parallel
00822409033430	14 mm x 12 mm x Parallel
00822409033423	14 mm x 11 mm x Parallel
00822409033416	14 mm x 10 mm x Parallel
00822409033409	14 mm x 9 mm x Parallel
00822409033393	14 mm x 8 mm x Parallel
00822409033386	14 mm x 7 mm x Parallel
00822409033379	12 mm x 7 mm x 7 Degree Lordotic
00822409033362	12 mm x 6 mm x 7 Degree Lordotic
00822409033355	12 mm x 5 mm x 7 Degree Lordotic
00822409033232	14 mm x 12 mm x 7 Degree Lordotic
00822409033225	14 mm x 11 mm x 7 Degree Lordotic
00822409033218	14 mm x 10 mm x 7 Degree Lordotic
00822409033201	14 mm x 9 mm x 7 Degree Lordotic
00822409033195	14 mm x 8 mm x 7 Degree Lordotic
00822409033188	14 mm x 7 mm x 7 Degree Lordotic
00822409033171	14 mm x 6 mm x 7 Degree Lordotic
00822409033164	14 mm x 5 mm x 7 Degree Lordotic
00822409033157	12 mm x 12 mm x 7 Degree Lordotic
00822409033140	12 mm x 11 mm x 7 Degree Lordotic
00822409033133	12 mm x 10 mm x 7 Degree Lordotic
00822409033126	12 mm x 9 mm x 7 Degree Lordotic
00822409033119	12 mm x 8 mm x 7 Degree Lordotic
00822409025626	16 mm x 12 mm x 7 Degree Lordotic
00822409025619	16 mm x 12 mm x Parallel