IdentiTi II

GUDID 00190376647548

IdentiTi II LIF 6 x 22 x 60 mm, 15°

ALPHATEC SPINE, INC.

Metallic spinal interbody fusion cage

Primary Device ID	00190376647548
NIH Device Record Key	47fa2d75-83dc-49a0-bbd7-c3bd304228c6
Commercial Distribution Status	In Commercial Distribution
Brand Name	IdentiTi II
Version Model Number	800-06226015-S
Company DUNS	602465783
Company Name	ALPHATEC SPINE, 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	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
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(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com

Device Dimensions

Width	22 Millimeter
Angle	15 degree
Length	60 Millimeter
Height	6 Millimeter
Width	22 Millimeter
Angle	15 degree
Length	60 Millimeter
Height	6 Millimeter
Width	22 Millimeter
Angle	15 degree
Length	60 Millimeter
Height	6 Millimeter
Width	22 Millimeter
Angle	15 degree
Length	60 Millimeter
Height	6 Millimeter
Width	22 Millimeter
Angle	15 degree
Length	60 Millimeter
Height	6 Millimeter
Width	22 Millimeter
Angle	15 degree
Length	60 Millimeter
Height	6 Millimeter
Width	22 Millimeter
Angle	15 degree
Length	60 Millimeter
Height	6 Millimeter
Width	22 Millimeter
Angle	15 degree
Length	60 Millimeter
Height	6 Millimeter
Width	22 Millimeter
Angle	15 degree
Length	60 Millimeter
Height	6 Millimeter
Width	22 Millimeter
Angle	15 degree
Length	60 Millimeter
Height	6 Millimeter
Width	22 Millimeter
Angle	15 degree
Length	60 Millimeter
Height	6 Millimeter
Width	22 Millimeter
Angle	15 degree
Length	60 Millimeter
Height	6 Millimeter
Width	22 Millimeter
Angle	15 degree
Length	60 Millimeter
Height	6 Millimeter
Width	22 Millimeter
Angle	15 degree
Length	60 Millimeter
Height	6 Millimeter
Width	22 Millimeter
Angle	15 degree
Length	60 Millimeter
Height	6 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190376647548 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K242364

FDA Product Code

PHM	Intervertebral fusion device with bone graft, thoracic

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2025-03-28
Device Publish Date	2025-03-20

On-Brand Devices [IdentiTi II]

00190376643816	IdentiTi II PC Instruments Alpha
00190376643762	IdentiTi II PC 9 x 10 x 40mm, 5°
00190376643755	IdentiTi II PC 8 x 10 x 40mm, 5°
00190376643748	IdentiTi II PC 7 x 10 x 40mm, 5°
00190376616162	IdentiTi II PC 12 x 10 x 30mm, 10°
00190376616155	IdentiTi II PC 12 x 10 x 30mm, 5°
00190376616148	IdentiTi II PC 11 x 10 x 35mm, 15°
00190376616131	IdentiTi II PC 11 x 10 x 35mm, 10°
00190376616124	IdentiTi II PC 11 x 10 x 30mm, 10°
00190376616117	IdentiTi II PC 11 x 10 x 30mm, 5°
00190376616100	IdentiTi II PC 11 x 10 x 25mm, 5°
00190376616094	IdentiTi II PC 10 x 10 x 35mm, 15°
00190376616087	IdentiTi II PC 10 x 10 x 35mm, 10°
00190376616070	IdentiTi II PC 10 x 10 x 30mm, 10°
00190376616063	IdentiTi II PC 10 x 10 x 30mm, 5°
00190376616056	IdentiTi II PC 10 x 10 x 25mm, 5°
00190376616049	IdentiTi II PC 9 x 10 x 35mm, 15°
00190376616032	IdentiTi II PC 9 x 10 x 35mm, 10°
00190376616025	IdentiTi II PC 9 x 10 x 30mm, 15°
00190376616018	IdentiTi II PC 9 x 10 x 30mm, 10°
00190376616001	IdentiTi II PC 9 x 10 x 30mm, 5°
00190376615998	IdentiTi II PC 9 x 10 x 25mm, 5°
00190376615981	IdentiTi II PC 8 x 12 x 35mm, 15°
00190376615974	IdentiTi II PC 8 x 12 x 30mm, 10°
00190376615967	IdentiTi II PC 8 x 10 x 35mm, 15°
00190376615950	IdentiTi II PC 8 x 10 x 35mm, 10°
00190376615943	IdentiTi II PC 8 x 10 x 30mm, 15°
00190376615936	IdentiTi II PC 8 x 10 x 30mm, 10°
00190376615929	IdentiTi II PC 8 x 10 x 30mm, 5°
00190376615912	IdentiTi II PC 8 x 10 x 25mm, 5°
00190376615905	IdentiTi II PC 7 x 12 x 35mm, 15°
00190376615899	IdentiTi II PC 7 x 12 x 30mm, 10°
00190376615882	IdentiTi II PC 7 x 10 x 35mm, 15°
00190376615875	IdentiTi II PC 7 x 10 x 35mm, 10°
00190376615868	IdentiTi II PC 7 x 10 x 30mm, 15°
00190376615851	IdentiTi II PC 7 x 10 x 30mm, 10°
00190376615844	IdentiTi II PC 7 x 10 x 30mm, 5°
00190376615837	IdentiTi II PC 7 x 10 x 25mm, 5°
00190376615820	IdentiTi II PC 6 x 10 x 35mm, 15°
00190376615813	IdentiTi II PC 6 x 10 x 35mm, 10°
00190376615806	IdentiTi II PC 6 x 10 x 30mm, 15°
00190376615790	IdentiTi II PC 6 x 10 x 30mm, 10°
00190376615783	IdentiTi II PC 6 x 10 x 30mm, 5°
00190376615776	IdentiTi II PC 6 x 10 x 25mm, 5°
00190376599755	ID II PC, INTRADISCAL DISTRACTOR TIP, 10mm
00190376599748	ID II PC, INTRADISCAL DISTRACTOR TIP, 9mm
00190376599731	ID II PC, INTRADISCAL DISTRACTOR TIP, 8mm
00190376599724	ID II PC, INTRADISCAL DISTRACTOR TIP, 7mm
00190376599717	ID II PC, INTRADISCAL DISTRACTOR TIP, 6mm
00190376599700	ID II PC, INTRADISCAL DISTRACTOR TIP, 5mm