IDENTITi NANOTEC

GUDID 00190376361031

IDENTITi NANOTEC LIF POROUS Ti SPACER, 10 x 22 x 65 mm, 15°

ALPHATEC SPINE, INC.

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• Primary Device ID: 00190376361031
• NIH Device Record Key: 5e435c6d-384f-432d-92c2-b86861fe0579
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IDENTITi NANOTEC
• Version Model Number: 100-PRO-10226515-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: true
• 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
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com

Device Dimensions

• Angle: 15 degree
• Height: 10 Millimeter
• Width: 22 Millimeter
• Length: 65 Millimeter
• Angle: 15 degree
• Height: 10 Millimeter
• Width: 22 Millimeter
• Length: 65 Millimeter
• Angle: 15 degree
• Height: 10 Millimeter
• Width: 22 Millimeter
• Length: 65 Millimeter
• Angle: 15 degree
• Height: 10 Millimeter
• Width: 22 Millimeter
• Length: 65 Millimeter
• Angle: 15 degree
• Height: 10 Millimeter
• Width: 22 Millimeter
• Length: 65 Millimeter
• Angle: 15 degree
• Height: 10 Millimeter
• Width: 22 Millimeter
• Length: 65 Millimeter
• Angle: 15 degree
• Height: 10 Millimeter
• Width: 22 Millimeter
• Length: 65 Millimeter
• Angle: 15 degree
• Height: 10 Millimeter
• Width: 22 Millimeter
• Length: 65 Millimeter
• Angle: 15 degree
• Height: 10 Millimeter
• Width: 22 Millimeter
• Length: 65 Millimeter
• Angle: 15 degree
• Height: 10 Millimeter
• Width: 22 Millimeter
• Length: 65 Millimeter
• Angle: 15 degree
• Height: 10 Millimeter
• Width: 22 Millimeter
• Length: 65 Millimeter
• Angle: 15 degree
• Height: 10 Millimeter
• Width: 22 Millimeter
• Length: 65 Millimeter
• Angle: 15 degree
• Height: 10 Millimeter
• Width: 22 Millimeter
• Length: 65 Millimeter
• Angle: 15 degree
• Height: 10 Millimeter
• Width: 22 Millimeter
• Length: 65 Millimeter
• Angle: 15 degree
• Height: 10 Millimeter
• Width: 22 Millimeter
• Length: 65 Millimeter
• Angle: 15 degree
• Height: 10 Millimeter
• Width: 22 Millimeter
• Length: 65 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190376361031 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211805

FDA Product Code

• OVD: Intervertebral fusion device with integrated fixation, 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: 2022-01-06
• Device Publish Date: 2021-12-29

On-Brand Devices [IDENTITi NANOTEC]

• 00190376364360: IDENTITi NANOTEC LIF POROUS Ti SPACER, 16 x 26 x 65 mm, 0°
• 00190376364353: IDENTITi NANOTEC LIF POROUS Ti SPACER, 16 x 26 x 60 mm, 0°
• 00190376364346: IDENTITi NANOTEC LIF POROUS Ti SPACER, 16 x 26 x 55 mm, 0°
• 00190376364339: IDENTITi NANOTEC LIF POROUS Ti SPACER, 16 x 26 x 50 mm, 0°
• 00190376364322: IDENTITi NANOTEC LIF POROUS Ti SPACER, 16 x 26 x 45 mm, 0°
• 00190376364315: IDENTITi NANOTEC LIF POROUS Ti SPACER, 16 x 26 x 40 mm, 0°
• 00190376364308: IDENTITi NANOTEC LIF POROUS Ti SPACER, 16 x 22 x 65 mm, 0°
• 00190376364292: IDENTITi NANOTEC LIF POROUS Ti SPACER, 16 x 22 x 60 mm, 0°
• 00190376364285: IDENTITi NANOTEC LIF POROUS Ti SPACER, 16 x 22 x 55 mm, 0°
• 00190376364278: IDENTITi NANOTEC LIF POROUS Ti SPACER, 16 x 22 x 50 mm, 0°
• 00190376364261: IDENTITi NANOTEC LIF POROUS Ti SPACER, 16 x 22 x 45 mm, 0°
• 00190376364254: IDENTITi NANOTEC LIF POROUS Ti SPACER, 16 x 22 x 40 mm, 0°
• 00190376364247: IDENTITi NANOTEC LIF POROUS Ti SPACER, 15 x 26 x 65 mm, 0°
• 00190376364230: IDENTITi NANOTEC LIF POROUS Ti SPACER, 15 x 26 x 60 mm, 0°
• 00190376364223: IDENTITi NANOTEC LIF POROUS Ti SPACER, 15 x 26 x 55 mm, 0°
• 00190376364216: IDENTITi NANOTEC LIF POROUS Ti SPACER, 15 x 26 x 50 mm, 0°
• 00190376364209: IDENTITi NANOTEC LIF POROUS Ti SPACER, 15 x 26 x 45 mm, 0°
• 00190376364193: IDENTITi NANOTEC LIF POROUS Ti SPACER, 15 x 26 x 40 mm, 0°
• 00190376364186: IDENTITi NANOTEC LIF POROUS Ti SPACER, 15 x 22 x 65 mm, 0°
• 00190376364179: IDENTITi NANOTEC LIF POROUS Ti SPACER, 15 x 22 x 60 mm, 0°
• 00190376364162: IDENTITi NANOTEC LIF POROUS Ti SPACER, 15 x 22 x 55 mm, 0°
• 00190376364155: IDENTITi NANOTEC LIF POROUS Ti SPACER, 15 x 22 x 50 mm, 0°
• 00190376364148: IDENTITi NANOTEC LIF POROUS Ti SPACER, 15 x 22 x 45 mm, 0°
• 00190376364131: IDENTITi NANOTEC LIF POROUS Ti SPACER, 15 x 22 x 40 mm, 0°
• 00190376364124: IDENTITi NANOTEC LIF-HL POROUS Ti SPACER, 14 x 26 x 65 mm, 20°
• 00190376364117: IDENTITi NANOTEC LIF POROUS Ti SPACER, 14 x 26 x 65 mm, 15°
• 00190376364100: IDENTITi NANOTEC LIF POROUS Ti SPACER, 14 x 26 x 65 mm, 10°
• 00190376364094: IDENTITi NANOTEC LIF POROUS Ti SPACER, 14 x 26 x 65 mm, 5°
• 00190376364087: IDENTITi NANOTEC LIF POROUS Ti SPACER, 14 x 26 x 65 mm, 0°
• 00190376364070: IDENTITi NANOTEC LIF-HL POROUS Ti SPACER, 14 x 26 x 60 mm, 20°
• 00190376364063: IDENTITi NANOTEC LIF POROUS Ti SPACER, 14 x 26 x 60 mm, 15°
• 00190376364056: IDENTITi NANOTEC LIF POROUS Ti SPACER, 14 x 26 x 60 mm, 10°
• 00190376364049: IDENTITi NANOTEC LIF POROUS Ti SPACER, 14 x 26 x 60 mm, 5°
• 00190376364032: IDENTITi NANOTEC LIF POROUS Ti SPACER, 14 x 26 x 60 mm, 0°
• 00190376364025: IDENTITi NANOTEC LIF-HL POROUS Ti SPACER, 14 x 26 x 55 mm, 20°
• 00190376364018: IDENTITi NANOTEC LIF POROUS Ti SPACER, 14 x 26 x 55 mm, 15°
• 00190376364001: IDENTITi NANOTEC LIF POROUS Ti SPACER, 14 x 26 x 55 mm, 10°
• 00190376363998: IDENTITi NANOTEC LIF POROUS Ti SPACER, 14 x 26 x 55 mm, 5°
• 00190376363981: IDENTITi NANOTEC LIF POROUS Ti SPACER, 14 x 26 x 55 mm, 0°
• 00190376363974: IDENTITi NANOTEC LIF-HL POROUS Ti SPACER, 14 x 26 x 50 mm, 20°
• 00190376363967: IDENTITi NANOTEC LIF POROUS Ti SPACER, 14 x 26 x 50 mm, 15°
• 00190376363950: IDENTITi NANOTEC LIF POROUS Ti SPACER, 14 x 26 x 50 mm, 10°
• 00190376363943: IDENTITi NANOTEC LIF POROUS Ti SPACER, 14 x 26 x 50 mm, 5°
• 00190376363936: IDENTITi NANOTEC LIF POROUS Ti SPACER, 14 x 26 x 50 mm, 0°
• 00190376363929: IDENTITi NANOTEC LIF-HL POROUS Ti SPACER, 14 x 26 x 45 mm, 20°
• 00190376363912: IDENTITi NANOTEC LIF POROUS Ti SPACER, 14 x 26 x 45 mm, 15°
• 00190376363905: IDENTITi NANOTEC LIF POROUS Ti SPACER, 14 x 26 x 45 mm, 10°
• 00190376363899: IDENTITi NANOTEC LIF POROUS Ti SPACER, 14 x 26 x 45 mm, 5°
• 00190376363882: IDENTITi NANOTEC LIF POROUS Ti SPACER, 14 x 26 x 45 mm, 0°
• 00190376363875: IDENTITi NANOTEC LIF-HL POROUS Ti SPACER, 14 x 26 x 40 mm, 20°