IdentiTi

GUDID 00190376533995

IDENTITi SPS pTi SPACER, 7 x 18 x 15 mm, 10°

ALPHATEC SPINE, INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 00190376533995
• NIH Device Record Key: f30edffb-8fa7-4a30-a76c-c6d4c7be5394
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IdentiTi
• Version Model Number: 334-07181510-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: 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
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com

Device Dimensions

• Height: 7 Millimeter
• Width: 18 Millimeter
• Depth: 15 Millimeter
• Angle: 10 degree
• Height: 7 Millimeter
• Width: 18 Millimeter
• Depth: 15 Millimeter
• Angle: 10 degree
• Height: 7 Millimeter
• Width: 18 Millimeter
• Depth: 15 Millimeter
• Angle: 10 degree
• Height: 7 Millimeter
• Width: 18 Millimeter
• Depth: 15 Millimeter
• Angle: 10 degree
• Height: 7 Millimeter
• Width: 18 Millimeter
• Depth: 15 Millimeter
• Angle: 10 degree
• Height: 7 Millimeter
• Width: 18 Millimeter
• Depth: 15 Millimeter
• Angle: 10 degree
• Height: 7 Millimeter
• Width: 18 Millimeter
• Depth: 15 Millimeter
• Angle: 10 degree
• Height: 7 Millimeter
• Width: 18 Millimeter
• Depth: 15 Millimeter
• Angle: 10 degree
• Height: 7 Millimeter
• Width: 18 Millimeter
• Depth: 15 Millimeter
• Angle: 10 degree
• Height: 7 Millimeter
• Width: 18 Millimeter
• Depth: 15 Millimeter
• Angle: 10 degree
• Height: 7 Millimeter
• Width: 18 Millimeter
• Depth: 15 Millimeter
• Angle: 10 degree
• Height: 7 Millimeter
• Width: 18 Millimeter
• Depth: 15 Millimeter
• Angle: 10 degree
• Height: 7 Millimeter
• Width: 18 Millimeter
• Depth: 15 Millimeter
• Angle: 10 degree
• Height: 7 Millimeter
• Width: 18 Millimeter
• Depth: 15 Millimeter
• Angle: 10 degree
• Height: 7 Millimeter
• Width: 18 Millimeter
• Depth: 15 Millimeter
• Angle: 10 degree
• Height: 7 Millimeter
• Width: 18 Millimeter
• Depth: 15 Millimeter
• Angle: 10 degree
• Height: 7 Millimeter
• Width: 18 Millimeter
• Depth: 15 Millimeter
• Angle: 10 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190376533995 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233640

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: 2024-06-10
• Device Publish Date: 2024-06-02

On-Brand Devices [IdentiTi]

• 00190376182452: IdentiTi Cervical Porous Ti Spacer, 8 x 14 x 12 mm, 7°
• 00190376182360: IdentiTi Cervical Porous Ti Spacer, 7 x 18 x 16 mm, 10°
• 00190376182353: IdentiTi Cervical Porous Ti Spacer, 7 x 18 x 16 mm, 7°
• 00190376182308: IdentiTi Cervical Porous Ti Spacer, 7 x 16 x 14 mm, 10°
• 00190376182292: IdentiTi Cervical Porous Ti Spacer, 7 x 16 x 14 mm, 7°
• 00190376182254: IdentiTi Cervical Porous Ti Spacer, 6 x 18 x 16 mm, 10°
• 00190376182247: IdentiTi Cervical Porous Ti Spacer, 6 x 18 x 16 mm, 7°
• 00190376182209: IdentiTi Cervical Porous Ti Spacer, 6 x 16 x 14 mm, 10°
• 00190376182193: IdentiTi Cervical Porous Ti Spacer, 6 x 16 x 14 mm, 7°
• 00190376182131: IdentiTi Cervical Porous Ti Spacer, 6 x 14 x 12 mm, 7°
• 00190376182070: IdentiTi Cervical Porous Ti Spacer, 5 x 18 x 16 mm, 7°
• 00190376182049: IdentiTi Cervical Porous Ti Spacer, 5 x 16 x 14 mm, 7°
• 00190376180939: IdentiTi Cervical Porous Ti Spacer, 9 x 18 x 16 mm, 10°
• 00190376180922: IdentiTi Cervical Porous Ti Spacer, 9 x 18 x 16 mm, 7°
• 00190376180878: IdentiTi Cervical Porous Ti Spacer, 9 x 16 x 14 mm, 10°
• 00190376180861: IdentiTi Cervical Porous Ti Spacer, 9 x 16 x 14 mm, 7°
• 00190376180809: IdentiTi Cervical Porous Ti Spacer, 9 x 14 x 12 mm, 7°
• 00190376180694: IdentiTi Cervical Porous Ti Spacer, 8 x 18 x 16 mm, 10°
• 00190376180687: IdentiTi Cervical Porous Ti Spacer, 8 x 18 x 16 mm, 7°
• 00190376180632: IdentiTi Cervical Porous Ti Spacer, 8 x 16 x 14 mm, 10°
• 00190376180625: IdentiTi Cervical Porous Ti Spacer, 8 x 16 x 14 mm, 7°
• 00190376180564: IdentiTi Cervical Porous Ti Spacer, 7 x 14 x 12 mm, 7°
• 00190376180465: IdentiTi Cervical Porous Ti Spacer, 5 x 14 x 12 mm, 7°
• 00190376218625: IDENTITi ALIF POROUS Ti SPACER, SW, 7 x 38 x 28 mm, 10°
• 00190376218601: IDENTITi ALIF POROUS Ti SPACER, SW, 6 x 38 x 28 mm, 30°
• 00190376218595: IDENTITi ALIF POROUS Ti SPACER, SW, 6 x 38 x 28 mm, 20°
• 00190376218588: IDENTITI ALIF POROUS TI SPACER, SW, 13 X 38 X 28 MM, 10°
• 00190376218571: IDENTITI ALIF POROUS TI SPACER, SW, 12 X 34 X 24 MM, 15°
• 00190376218564: IDENTITI ALIF POROUS TI SPACER, SW, 12 X 34 X 24 MM, 10°
• 00190376218540: IDENTITi ALIF POROUS Ti SPACER, SW, 11 x 38 x 28 mm, 15°
• 00190376218533: IDENTITi ALIF POROUS Ti SPACER, SW, 11 x 38 x 28 mm, 10°
• 00190376218519: IDENTITi ALIF POROUS Ti SPACER, SW, 10 x 34 x 24 mm, 15°
• 00190376218502: IDENTITi ALIF POROUS Ti SPACER, SW, 10 x 34 x 24 mm, 10°
• 00190376218472: IDENTITi ALIF POROUS Ti SPACER, SW, 9 x 38 x 28 mm, 15°
• 00190376218465: IDENTITi ALIF POROUS Ti SPACER, SW, 9 x 38 x 28 mm, 10°
• 00190376218441: IDENTITi ALIF POROUS Ti SPACER, SW, 8 x 38 x 28 mm, 30°
• 00190376218434: IDENTITi ALIF POROUS Ti SPACER, SW, 8 x 38 x 28 mm, 20°
• 00190376218427: IDENTITi ALIF POROUS Ti SPACER, SW, 8 x 34 x 24 mm, 30°
• 00190376218410: IDENTITi ALIF POROUS Ti SPACER, SW, 8 x 34 x 24 mm, 20°
• 00190376218403: IDENTITi ALIF POROUS Ti SPACER, SW, 8 x 34 x 24 mm, 15°
• 00190376218397: IDENTITi ALIF POROUS Ti SPACER, SW, 8 x 34 x 24 mm, 10°
• 00190376218366: IDENTITi ALIF POROUS Ti SPACER, SW, 7 x 38 x 28 mm, 15°
• 00190376218359: IDENTITi ALIF POROUS Ti SPACER, SW, 6 x 34 x 24 mm, 30°
• 00190376218342: IDENTITi ALIF POROUS Ti SPACER, SW, 6 x 34 x 24 mm, 20°
• 00190376218335: IDENTITi ALIF POROUS Ti SPACER, SW, 6 x 34 x 24 mm, 15°
• 00190376218328: IDENTITi ALIF POROUS Ti SPACER, SW, 6 x 34 x 24 mm, 10°
• 00190376218304: IDENTITi ALIF POROUS Ti SPACER, SW, 5 x 38 x 28 mm, 15°
• 00190376218298: IDENTITi ALIF POROUS Ti SPACER, SW, 5 x 38 x 28 mm, 10°
• 00190376218281: IDENTITi ALIF POROUS Ti SPACER, SW, 4 x 38 x 28 mm, 30°
• 00190376218274: IDENTITi ALIF POROUS Ti SPACER, SW, 4 x 38 x 28 mm, 20°