TRANSCEND NANOTEC

GUDID 00190376336176

TRANSCEND NANOTEC LIF-HL PEEK SPACER, 8 x 18 x 45 mm, 25°

ALPHATEC SPINE, INC.

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• Primary Device ID: 00190376336176
• NIH Device Record Key: bd81b99a-1111-4510-9543-0b1b6c5b6f8f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRANSCEND NANOTEC
• Version Model Number: 101-PRO-08184525-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

• Height: 8 Millimeter
• Width: 18 Millimeter
• Angle: 25 degree
• Length: 45 Millimeter
• Height: 8 Millimeter
• Width: 18 Millimeter
• Angle: 25 degree
• Length: 45 Millimeter
• Height: 8 Millimeter
• Width: 18 Millimeter
• Angle: 25 degree
• Length: 45 Millimeter
• Height: 8 Millimeter
• Width: 18 Millimeter
• Angle: 25 degree
• Length: 45 Millimeter
• Height: 8 Millimeter
• Width: 18 Millimeter
• Angle: 25 degree
• Length: 45 Millimeter
• Height: 8 Millimeter
• Width: 18 Millimeter
• Angle: 25 degree
• Length: 45 Millimeter
• Height: 8 Millimeter
• Width: 18 Millimeter
• Angle: 25 degree
• Length: 45 Millimeter
• Height: 8 Millimeter
• Width: 18 Millimeter
• Angle: 25 degree
• Length: 45 Millimeter
• Height: 8 Millimeter
• Width: 18 Millimeter
• Angle: 25 degree
• Length: 45 Millimeter
• Height: 8 Millimeter
• Width: 18 Millimeter
• Angle: 25 degree
• Length: 45 Millimeter
• Height: 8 Millimeter
• Width: 18 Millimeter
• Angle: 25 degree
• Length: 45 Millimeter
• Height: 8 Millimeter
• Width: 18 Millimeter
• Angle: 25 degree
• Length: 45 Millimeter
• Height: 8 Millimeter
• Width: 18 Millimeter
• Angle: 25 degree
• Length: 45 Millimeter
• Height: 8 Millimeter
• Width: 18 Millimeter
• Angle: 25 degree
• Length: 45 Millimeter
• Height: 8 Millimeter
• Width: 18 Millimeter
• Angle: 25 degree
• Length: 45 Millimeter
• Height: 8 Millimeter
• Width: 18 Millimeter
• Angle: 25 degree
• Length: 45 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190376336176 [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 [TRANSCEND NANOTEC]

• 00190376349169: TRANSCEND NANOTEC LIF PEEK SPACER, 16 x 26 x 65 mm, 0°
• 00190376349152: TRANSCEND NANOTEC LIF PEEK SPACER, 16 x 26 x 60 mm, 0°
• 00190376349145: TRANSCEND NANOTEC LIF PEEK SPACER, 16 x 26 x 55 mm, 0°
• 00190376349138: TRANSCEND NANOTEC LIF PEEK SPACER, 16 x 26 x 50 mm, 0°
• 00190376349121: TRANSCEND NANOTEC LIF PEEK SPACER, 16 x 26 x 45 mm, 0°
• 00190376349114: TRANSCEND NANOTEC LIF PEEK SPACER, 16 x 26 x 40 mm, 0°
• 00190376349107: TRANSCEND NANOTEC LIF PEEK SPACER, 15 x 26 x 65 mm, 0°
• 00190376349091: TRANSCEND NANOTEC LIF PEEK SPACER, 15 x 26 x 60 mm, 0°
• 00190376349084: TRANSCEND NANOTEC LIF PEEK SPACER, 15 x 26 x 55 mm, 0°
• 00190376349077: TRANSCEND NANOTEC LIF PEEK SPACER, 15 x 26 x 50 mm, 0°
• 00190376349060: TRANSCEND NANOTEC LIF PEEK SPACER, 15 x 26 x 45 mm, 0°
• 00190376349053: TRANSCEND NANOTEC LIF PEEK SPACER, 15 x 26 x 40 mm, 0°
• 00190376349046: TRANSCEND NANOTEC LIF-HL PEEK SPACER, 14 x 26 x 65 mm, 20°
• 00190376349039: TRANSCEND NANOTEC LIF PEEK SPACER, 14 x 26 x 65 mm, 15°
• 00190376349022: TRANSCEND NANOTEC LIF PEEK SPACER, 14 x 26 x 65 mm, 10°
• 00190376349015: TRANSCEND NANOTEC LIF PEEK SPACER, 14 x 26 x 65 mm, 5°
• 00190376349008: TRANSCEND NANOTEC LIF PEEK SPACER, 14 x 26 x 65 mm, 0°
• 00190376348995: TRANSCEND NANOTEC LIF-HL PEEK SPACER, 14 x 26 x 60 mm, 20°
• 00190376348988: TRANSCEND NANOTEC LIF PEEK SPACER, 14 x 26 x 60 mm, 15°
• 00190376348971: TRANSCEND NANOTEC LIF PEEK SPACER, 14 x 26 x 60 mm, 10°
• 00190376348964: TRANSCEND NANOTEC LIF PEEK SPACER, 14 x 26 x 60 mm, 5°
• 00190376348957: TRANSCEND NANOTEC LIF PEEK SPACER, 14 x 26 x 60 mm, 0°
• 00190376348940: TRANSCEND NANOTEC LIF-HL PEEK SPACER, 14 x 26 x 55 mm, 20°
• 00190376348933: TRANSCEND NANOTEC LIF PEEK SPACER, 14 x 26 x 55 mm, 15°
• 00190376348926: TRANSCEND NANOTEC LIF PEEK SPACER, 14 x 26 x 55 mm, 10°
• 00190376348919: TRANSCEND NANOTEC LIF PEEK SPACER, 14 x 26 x 55 mm, 5°
• 00190376348902: TRANSCEND NANOTEC LIF PEEK SPACER, 14 x 26 x 55 mm, 0°
• 00190376348896: TRANSCEND NANOTEC LIF-HL PEEK SPACER, 14 x 26 x 50 mm, 20°
• 00190376348889: TRANSCEND NANOTEC LIF PEEK SPACER, 14 x 26 x 50 mm, 15°
• 00190376348872: TRANSCEND NANOTEC LIF PEEK SPACER, 14 x 26 x 50 mm, 10°
• 00190376348865: TRANSCEND NANOTEC LIF PEEK SPACER, 14 x 26 x 50 mm, 5°
• 00190376348858: TRANSCEND NANOTEC LIF PEEK SPACER, 14 x 26 x 50 mm, 0°
• 00190376348841: TRANSCEND NANOTEC LIF-HL PEEK SPACER, 14 x 26 x 45 mm, 20°
• 00190376348834: TRANSCEND NANOTEC LIF PEEK SPACER, 14 x 26 x 45 mm, 15°
• 00190376348827: TRANSCEND NANOTEC LIF PEEK SPACER, 14 x 26 x 45 mm, 10°
• 00190376348810: TRANSCEND NANOTEC LIF PEEK SPACER, 14 x 26 x 45 mm, 5°
• 00190376348803: TRANSCEND NANOTEC LIF PEEK SPACER, 14 x 26 x 45 mm, 0°
• 00190376348797: TRANSCEND NANOTEC LIF-HL PEEK SPACER, 14 x 26 x 40 mm, 20°
• 00190376348780: TRANSCEND NANOTEC LIF PEEK SPACER, 14 x 26 x 40 mm, 15°
• 00190376348773: TRANSCEND NANOTEC LIF PEEK SPACER, 14 x 26 x 40 mm, 10°
• 00190376348766: TRANSCEND NANOTEC LIF PEEK SPACER, 14 x 26 x 40 mm, 5°
• 00190376348759: TRANSCEND NANOTEC LIF PEEK SPACER, 14 x 26 x 40 mm, 0°
• 00190376348742: TRANSCEND NANOTEC LIF-HL PEEK SPACER, 13 x 26 x 65 mm, 20°
• 00190376348735: TRANSCEND NANOTEC LIF PEEK SPACER, 13 x 26 x 65 mm, 15°
• 00190376348728: TRANSCEND NANOTEC LIF PEEK SPACER, 13 x 26 x 65 mm, 10°
• 00190376348711: TRANSCEND NANOTEC LIF PEEK SPACER, 13 x 26 x 65 mm, 5°
• 00190376348704: TRANSCEND NANOTEC LIF PEEK SPACER, 13 x 26 x 65 mm, 0°
• 00190376348698: TRANSCEND NANOTEC LIF-HL PEEK SPACER, 13 x 26 x 60 mm, 20°
• 00190376348681: TRANSCEND NANOTEC LIF PEEK SPACER, 13 x 26 x 60 mm, 15°
• 00190376348674: TRANSCEND NANOTEC LIF PEEK SPACER, 13 x 26 x 60 mm, 10°