IdentiTi II

GUDID 00190376615783

IdentiTi II PC 6 x 10 x 30mm, 5°

ALPHATEC SPINE, INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 00190376615783
• NIH Device Record Key: 01de33e1-8885-4d28-985a-82f7a7a16bdc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IdentiTi II
• Version Model Number: 822-06103005-S
• Company DUNS: 602465783
• Company Name: ALPHATEC SPINE, 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: 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

Device Dimensions

• Height: 6 Millimeter
• Width: 10 Millimeter
• Angle: 5 degree
• Length: 30 Millimeter
• Height: 6 Millimeter
• Width: 10 Millimeter
• Angle: 5 degree
• Length: 30 Millimeter
• Height: 6 Millimeter
• Width: 10 Millimeter
• Angle: 5 degree
• Length: 30 Millimeter
• Height: 6 Millimeter
• Width: 10 Millimeter
• Angle: 5 degree
• Length: 30 Millimeter
• Height: 6 Millimeter
• Width: 10 Millimeter
• Angle: 5 degree
• Length: 30 Millimeter
• Height: 6 Millimeter
• Width: 10 Millimeter
• Angle: 5 degree
• Length: 30 Millimeter
• Height: 6 Millimeter
• Width: 10 Millimeter
• Angle: 5 degree
• Length: 30 Millimeter
• Height: 6 Millimeter
• Width: 10 Millimeter
• Angle: 5 degree
• Length: 30 Millimeter
• Height: 6 Millimeter
• Width: 10 Millimeter
• Angle: 5 degree
• Length: 30 Millimeter
• Height: 6 Millimeter
• Width: 10 Millimeter
• Angle: 5 degree
• Length: 30 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190376615783 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242364

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

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: 2024-11-26
• Device Publish Date: 2024-11-18

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