IDENTITI TRANSCEND

GUDID 00190376410043

IDENTITi NanoTec CERVICAL POROUS Ti SPACER, 9 x 18 x 16 mm, 0°

ALPHATEC SPINE, INC.

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage

• Primary Device ID: 00190376410043
• NIH Device Record Key: e379ca9c-df9c-4268-8420-69ed59b56453
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IDENTITI TRANSCEND
• Version Model Number: 126-PRO-09181600-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

• Width: 18 Millimeter
• Height: 9 Millimeter
• Depth: 16 Millimeter
• Width: 18 Millimeter
• Height: 9 Millimeter
• Depth: 16 Millimeter
• Width: 18 Millimeter
• Height: 9 Millimeter
• Depth: 16 Millimeter
• Width: 18 Millimeter
• Height: 9 Millimeter
• Depth: 16 Millimeter
• Width: 18 Millimeter
• Height: 9 Millimeter
• Depth: 16 Millimeter
• Width: 18 Millimeter
• Height: 9 Millimeter
• Depth: 16 Millimeter
• Width: 18 Millimeter
• Height: 9 Millimeter
• Depth: 16 Millimeter
• Width: 18 Millimeter
• Height: 9 Millimeter
• Depth: 16 Millimeter
• Width: 18 Millimeter
• Height: 9 Millimeter
• Depth: 16 Millimeter
• Width: 18 Millimeter
• Height: 9 Millimeter
• Depth: 16 Millimeter
• Width: 18 Millimeter
• Height: 9 Millimeter
• Depth: 16 Millimeter
• Width: 18 Millimeter
• Height: 9 Millimeter
• Depth: 16 Millimeter
• Width: 18 Millimeter
• Height: 9 Millimeter
• Depth: 16 Millimeter
• Width: 18 Millimeter
• Height: 9 Millimeter
• Depth: 16 Millimeter
• Width: 18 Millimeter
• Height: 9 Millimeter
• Depth: 16 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190376410043 [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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• 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°
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• 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°