Transcend NanoTec

GUDID 00190376661421

SPS Inserter, Draw Rod

ALPHATEC SPINE, INC.

Orthopaedic inorganic implant inserter/extractor, reusable

• Primary Device ID: 00190376661421
• NIH Device Record Key: 6836002d-8441-4d27-8541-4fd91f6f6f6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Transcend NanoTec
• Version Model Number: 439-0001-03
• 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: false
• 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(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 Identifiers

Device Issuing Agency	Device ID
GS1	00190376661421 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251080

FDA Product Code

• ODP: Intervertebral fusion device with bone graft, cervical

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00190376661421]

Moist Heat or Steam Sterilization

[00190376661421]

Moist Heat or Steam Sterilization

[00190376661421]

Moist Heat or Steam Sterilization

[00190376661421]

Moist Heat or Steam Sterilization

[00190376661421]

Moist Heat or Steam Sterilization

[00190376661421]

Moist Heat or Steam Sterilization

[00190376661421]

Moist Heat or Steam Sterilization

[00190376661421]

Moist Heat or Steam Sterilization

[00190376661421]

Moist Heat or Steam Sterilization

[00190376661421]

Moist Heat or Steam Sterilization

[00190376661421]

Moist Heat or Steam Sterilization

[00190376661421]

Moist Heat or Steam Sterilization

[00190376661421]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-22
• Device Publish Date: 2025-08-14

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°