IDENTITI TRANSCEND

GUDID 00190376418087

IDENTITi NanoTec CERVICAL POROUS Ti SPACER, 5 x 14 x 12 mm, 0°

ALPHATEC SPINE, INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 00190376418087
• NIH Device Record Key: 3acec6f9-e835-4051-8611-37882599cb23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IDENTITI TRANSCEND
• Version Model Number: 126-PRO-05141200-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: 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
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com

Device Dimensions

• Height: 5 Millimeter
• Depth: 12 Millimeter
• Width: 14 Millimeter
• Height: 5 Millimeter
• Depth: 12 Millimeter
• Width: 14 Millimeter
• Height: 5 Millimeter
• Depth: 12 Millimeter
• Width: 14 Millimeter
• Height: 5 Millimeter
• Depth: 12 Millimeter
• Width: 14 Millimeter
• Height: 5 Millimeter
• Depth: 12 Millimeter
• Width: 14 Millimeter
• Height: 5 Millimeter
• Depth: 12 Millimeter
• Width: 14 Millimeter
• Height: 5 Millimeter
• Depth: 12 Millimeter
• Width: 14 Millimeter
• Height: 5 Millimeter
• Depth: 12 Millimeter
• Width: 14 Millimeter
• Height: 5 Millimeter
• Depth: 12 Millimeter
• Width: 14 Millimeter
• Height: 5 Millimeter
• Depth: 12 Millimeter
• Width: 14 Millimeter
• Height: 5 Millimeter
• Depth: 12 Millimeter
• Width: 14 Millimeter
• Height: 5 Millimeter
• Depth: 12 Millimeter
• Width: 14 Millimeter
• Height: 5 Millimeter
• Depth: 12 Millimeter
• Width: 14 Millimeter
• Height: 5 Millimeter
• Depth: 12 Millimeter
• Width: 14 Millimeter
• Height: 5 Millimeter
• Depth: 12 Millimeter
• Width: 14 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190376418087 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211805

FDA Product Code

• ODP: Intervertebral fusion device with bone graft, cervical

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: 2022-05-09
• Device Publish Date: 2022-05-01

On-Brand Devices [IDENTITI TRANSCEND]

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• 00190376422060: TRANSCEND NanoTec CERVICAL PEEK SPACER, 10 x 20 x 18 mm, 5°
• 00190376422053: TRANSCEND NanoTec CERVICAL PEEK SPACER, 10 x 20 x 18 mm, 0°
• 00190376422046: TRANSCEND NanoTec CERVICAL PEEK SPACER, 10 x 18 x 16 mm, 15°
• 00190376422039: TRANSCEND NanoTec CERVICAL PEEK SPACER, 10 x 18 x 16 mm, 12°
• 00190376422022: TRANSCEND NanoTec CERVICAL PEEK SPACER, 10 x 18 x 16 mm, 10°
• 00190376422015: TRANSCEND NanoTec CERVICAL PEEK SPACER, 10 x 18 x 16 mm, 7°
• 00190376422008: TRANSCEND NanoTec CERVICAL PEEK SPACER, 10 x 18 x 16 mm, 5°
• 00190376421995: TRANSCEND NanoTec CERVICAL PEEK SPACER, 10 x 18 x 16 mm, 0°
• 00190376421988: TRANSCEND NanoTec CERVICAL PEEK SPACER, 10 x 16 x 14 mm, 15°
• 00190376421971: TRANSCEND NanoTec CERVICAL PEEK SPACER, 10 x 16 x 14 mm, 12°
• 00190376421964: TRANSCEND NanoTec CERVICAL PEEK SPACER, 10 x 16 x 14 mm, 10°
• 00190376421957: TRANSCEND NanoTec CERVICAL PEEK SPACER, 10 x 16 x 14 mm, 7°
• 00190376421940: TRANSCEND NanoTec CERVICAL PEEK SPACER, 10 x 16 x 14 mm, 5°
• 00190376421933: TRANSCEND NanoTec CERVICAL PEEK SPACER, 10 x 16 x 14 mm, 0°
• 00190376421926: TRANSCEND NanoTec CERVICAL PEEK SPACER, 10 x 14 x 12 mm, 15°
• 00190376421919: TRANSCEND NanoTec CERVICAL PEEK SPACER, 10 x 14 x 12 mm, 12°
• 00190376421902: TRANSCEND NanoTec CERVICAL PEEK SPACER, 10 x 14 x 12 mm, 10°
• 00190376421896: TRANSCEND NanoTec CERVICAL PEEK SPACER, 10 x 14 x 12 mm, 7°
• 00190376421889: TRANSCEND NanoTec CERVICAL PEEK SPACER, 10 x 14 x 12 mm, 5°
• 00190376421872: TRANSCEND NanoTec CERVICAL PEEK SPACER, 10 x 14 x 12 mm, 0°
• 00190376421865: TRANSCEND NanoTec CERVICAL PEEK SPACER, 10 x 12 x 12 mm, 15°
• 00190376421858: TRANSCEND NanoTec CERVICAL PEEK SPACER, 10 x 12 x 12 mm, 12°
• 00190376421841: TRANSCEND NanoTec CERVICAL PEEK SPACER, 10 x 12 x 12 mm, 10°
• 00190376421834: TRANSCEND NanoTec CERVICAL PEEK SPACER, 10 x 12 x 12 mm, 7°
• 00190376421827: TRANSCEND NanoTec CERVICAL PEEK SPACER, 10 x 12 x 12 mm, 5°
• 00190376421810: TRANSCEND NanoTec CERVICAL PEEK SPACER, 10 x 12 x 12 mm, 0°
• 00190376421803: TRANSCEND NanoTec CERVICAL PEEK SPACER, 9 x 22 x 19 mm, 15°
• 00190376421797: TRANSCEND NanoTec CERVICAL PEEK SPACER, 9 x 22 x 19 mm, 12°
• 00190376421780: TRANSCEND NanoTec CERVICAL PEEK SPACER, 9 x 22 x 19 mm, 10°
• 00190376421773: TRANSCEND NanoTec CERVICAL PEEK SPACER, 9 x 22 x 19 mm, 7°
• 00190376421766: TRANSCEND NanoTec CERVICAL PEEK SPACER, 9 x 22 x 19 mm, 5°
• 00190376421759: TRANSCEND NanoTec CERVICAL PEEK SPACER, 9 x 22 x 19 mm, 0°
• 00190376421742: TRANSCEND NanoTec CERVICAL PEEK SPACER, 9 x 20 x 18 mm, 15°
• 00190376421735: TRANSCEND NanoTec CERVICAL PEEK SPACER, 9 x 20 x 18 mm, 12°
• 00190376421728: TRANSCEND NanoTec CERVICAL PEEK SPACER, 9 x 20 x 18 mm, 10°
• 00190376421711: TRANSCEND NanoTec CERVICAL PEEK SPACER, 9 x 20 x 18 mm, 7°
• 00190376421704: TRANSCEND NanoTec CERVICAL PEEK SPACER, 9 x 20 x 18 mm, 5°
• 00190376421698: TRANSCEND NanoTec CERVICAL PEEK SPACER, 9 x 20 x 18 mm, 0°
• 00190376421681: TRANSCEND NanoTec CERVICAL PEEK SPACER, 9 x 18 x 16 mm, 15°
• 00190376421674: TRANSCEND NanoTec CERVICAL PEEK SPACER, 9 x 18 x 16 mm, 12°
• 00190376421667: TRANSCEND NanoTec CERVICAL PEEK SPACER, 9 x 18 x 16 mm, 10°
• 00190376421650: TRANSCEND NanoTec CERVICAL PEEK SPACER, 9 x 18 x 16 mm, 7°
• 00190376421643: TRANSCEND NanoTec CERVICAL PEEK SPACER, 9 x 18 x 16 mm, 5°
• 00190376421636: TRANSCEND NanoTec CERVICAL PEEK SPACER, 9 x 18 x 16 mm, 0°
• 00190376421629: TRANSCEND NanoTec CERVICAL PEEK SPACER, 9 x 16 x 14 mm, 15°
• 00190376421612: TRANSCEND NanoTec CERVICAL PEEK SPACER, 9 x 16 x 14 mm, 12°
• 00190376421605: TRANSCEND NanoTec CERVICAL PEEK SPACER, 9 x 16 x 14 mm, 10°
• 00190376421599: TRANSCEND NanoTec CERVICAL PEEK SPACER, 9 x 16 x 14 mm, 7°
• 00190376421582: TRANSCEND NanoTec CERVICAL PEEK SPACER, 9 x 16 x 14 mm, 5°