Irix-C Cervical Integrated Fusion System

GUDID M697X066181408P1

IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 0°, 8mm

X-SPINE SYSTEMS, INC.

Polymeric spinal interbody fusion cage

Primary Device ID	M697X066181408P1
NIH Device Record Key	9f3c25c0-b2e1-4ff2-87c4-8b8d2dec53c2
Commercial Distribution Status	In Commercial Distribution
Brand Name	Irix-C Cervical Integrated Fusion System
Version Model Number	X066-181408P
Company DUNS	610042587
Company Name	X-SPINE SYSTEMS, INC.
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	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	+1(937)847-8400
Email	orders@x-spine.com
Phone	+1(937)847-8400
Email	orders@x-spine.com
Phone	+1(937)847-8400
Email	orders@x-spine.com
Phone	+1(937)847-8400
Email	orders@x-spine.com
Phone	+1(937)847-8400
Email	orders@x-spine.com
Phone	+1(937)847-8400
Email	orders@x-spine.com
Phone	+1(937)847-8400
Email	orders@x-spine.com
Phone	+1(937)847-8400
Email	orders@x-spine.com
Phone	+1(937)847-8400
Email	orders@x-spine.com
Phone	+1(937)847-8400
Email	orders@x-spine.com
Phone	+1(937)847-8400
Email	orders@x-spine.com
Phone	+1(937)847-8400
Email	orders@x-spine.com
Phone	+1(937)847-8400
Email	orders@x-spine.com
Phone	+1(937)847-8400
Email	orders@x-spine.com
Phone	+1(937)847-8400
Email	orders@x-spine.com
Phone	+1(937)847-8400
Email	orders@x-spine.com

Device Dimensions

Width	18 Millimeter
Height	8 Millimeter
Device Size Text, specify	0
Length	14 Millimeter
Width	18 Millimeter
Height	8 Millimeter
Device Size Text, specify	0
Length	14 Millimeter
Width	18 Millimeter
Height	8 Millimeter
Device Size Text, specify	0
Length	14 Millimeter
Width	18 Millimeter
Height	8 Millimeter
Device Size Text, specify	0
Length	14 Millimeter
Width	18 Millimeter
Height	8 Millimeter
Device Size Text, specify	0
Length	14 Millimeter
Width	18 Millimeter
Height	8 Millimeter
Device Size Text, specify	0
Length	14 Millimeter
Width	18 Millimeter
Height	8 Millimeter
Device Size Text, specify	0
Length	14 Millimeter
Width	18 Millimeter
Height	8 Millimeter
Device Size Text, specify	0
Length	14 Millimeter
Width	18 Millimeter
Height	8 Millimeter
Device Size Text, specify	0
Length	14 Millimeter
Width	18 Millimeter
Height	8 Millimeter
Device Size Text, specify	0
Length	14 Millimeter
Width	18 Millimeter
Height	8 Millimeter
Device Size Text, specify	0
Length	14 Millimeter
Width	18 Millimeter
Height	8 Millimeter
Device Size Text, specify	0
Length	14 Millimeter
Width	18 Millimeter
Height	8 Millimeter
Device Size Text, specify	0
Length	14 Millimeter
Width	18 Millimeter
Height	8 Millimeter
Device Size Text, specify	0
Length	14 Millimeter
Width	18 Millimeter
Height	8 Millimeter
Device Size Text, specify	0
Length	14 Millimeter
Width	18 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M697X066181408P1 [Primary]

FDA Product Code

OVE	Intervertebral fusion device with integrated fixation, cervical

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[M697X066181408P1]

Moist Heat or Steam Sterilization

[M697X066181408P1]

Moist Heat or Steam Sterilization

[M697X066181408P1]

Moist Heat or Steam Sterilization

[M697X066181408P1]

Moist Heat or Steam Sterilization

[M697X066181408P1]

Moist Heat or Steam Sterilization

[M697X066181408P1]

Moist Heat or Steam Sterilization

[M697X066181408P1]

Moist Heat or Steam Sterilization

[M697X066181408P1]

Moist Heat or Steam Sterilization

[M697X066181408P1]

Moist Heat or Steam Sterilization

[M697X066181408P1]

Moist Heat or Steam Sterilization

[M697X066181408P1]

Moist Heat or Steam Sterilization

[M697X066181408P1]

Moist Heat or Steam Sterilization

[M697X066181408P1]

Moist Heat or Steam Sterilization

[M697X066181408P1]

Moist Heat or Steam Sterilization

[M697X066181408P1]

Moist Heat or Steam Sterilization

[M697X066181408P1]

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	2015-10-12

On-Brand Devices [Irix-C Cervical Integrated Fusion System]

M697X066181412TPPC1	IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 0°, 12mm, PC
M697X066181412TP1	IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 0°, 12mm
M697X066181412TLPC1	IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 7°, 12mm, PC
M697X066181412TL1	IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 7°, 12mm
M697X066181412PPC1	IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 0°, 12mm, PC
M697X066181412P1	IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 0°, 12mm
M697X066181412LPC1	IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 7°, 12mm, PC
M697X066181412L1	IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 7°, 12mm
M697X066181411TPPC1	IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 0°, 11mm, PC
M697X066181411TP1	IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 0°, 11mm
M697X066181411TLPC1	IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 7°, 11mm, PC
M697X066181411TL1	IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 7°, 11mm
M697X066181411PPC1	IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 0°, 11mm, PC
M697X066181411P1	IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 0°, 11mm
M697X066181411LPC1	IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 7°, 11mm, PC
M697X066181411L1	IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 7°, 11mm
M697X066181410TPPC1	IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 0°, 10mm, PC
M697X066181410TP1	IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 0°, 10mm
M697X066181410TLPC1	IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 7°, 10mm, PC
M697X066181410TL1	IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 7°, 10mm
M697X066181410PPC1	IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 0°, 10mm, PC
M697X066181410P1	IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 0°, 10mm
M697X066181410LPC1	IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 7°, 10mm, PC
M697X066181410L1	IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 7°, 10mm
M697X066181409TPPC1	IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 0°, 9mm, PC
M697X066181409TP1	IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 0°, 9mm
M697X066181409TLPC1	IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 7°, 9mm, PC
M697X066181409TL1	IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 7°, 9mm
M697X066181409PPC1	IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 0°, 9mm, PC
M697X066181409P1	IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 0°, 9mm
M697X066181409LPC1	IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 7°, 9mm, PC
M697X066181409L1	IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 7°, 9mm
M697X066181408TPPC1	IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 0°, 8mm, PC
M697X066181408TP1	IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 0°, 8mm
M697X066181408TLPC1	IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 7°, 8mm, PC
M697X066181408TL1	IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 7°, 8mm
M697X066181408PPC1	IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 0°, 8mm, PC
M697X066181408P1	IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 0°, 8mm
M697X066181408LPC1	IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 7°, 8mm, PC
M697X066181408L1	IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 7°, 8mm
M697X066181407TPPC1	IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 0°, 7mm, PC
M697X066181407TP1	IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 0°, 7mm
M697X066181407TLPC1	IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 7°, 7mm, PC
M697X066181407TL1	IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 7°, 7mm
M697X066181407PPC1	IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 0°, 7mm, PC
M697X066181407P1	IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 0°, 7mm
M697X066181407LPC1	IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 7°, 7mm, PC
M697X066181407L1	IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 7°, 7mm
M697X066181406TPPC1	IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 0°, 6mm, PC
M697X066181406TP1	IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 0°, 6mm

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