Ascend

GUDID 00190376477398

12 mm EXPANDABLE CORE, 35-55 mm

ALPHATEC SPINE, INC.

Vertebral body prosthesis

• Primary Device ID: 00190376477398
• NIH Device Record Key: 22a89012-d86e-4c2d-b676-959cfce12cf0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ascend
• Version Model Number: 155-0-12-35
• 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
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com

Device Dimensions

• Height: 55 Millimeter
• Height: 35 Millimeter
• Height: 55 Millimeter
• Height: 35 Millimeter
• Height: 55 Millimeter
• Height: 35 Millimeter
• Height: 55 Millimeter
• Height: 35 Millimeter
• Height: 55 Millimeter
• Height: 35 Millimeter
• Height: 55 Millimeter
• Height: 35 Millimeter
• Height: 55 Millimeter
• Height: 35 Millimeter
• Height: 55 Millimeter
• Height: 35 Millimeter
• Height: 55 Millimeter
• Height: 35 Millimeter
• Height: 55 Millimeter
• Height: 35 Millimeter
• Height: 55 Millimeter
• Height: 35 Millimeter
• Height: 55 Millimeter
• Height: 35 Millimeter
• Height: 55 Millimeter
• Height: 35 Millimeter
• Height: 55 Millimeter
• Height: 35 Millimeter
• Height: 55 Millimeter
• Height: 35 Millimeter
• Height: 55 Millimeter
• Height: 35 Millimeter
• Height: 55 Millimeter
• Height: 35 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190376477398 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232173

FDA Product Code

• PLR: Spinal vertebral body replacement device - Cervical

Sterilization

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

[00190376477398]

Moist Heat or Steam Sterilization

[00190376477398]

Moist Heat or Steam Sterilization

[00190376477398]

Moist Heat or Steam Sterilization

[00190376477398]

Moist Heat or Steam Sterilization

[00190376477398]

Moist Heat or Steam Sterilization

[00190376477398]

Moist Heat or Steam Sterilization

[00190376477398]

Moist Heat or Steam Sterilization

[00190376477398]

Moist Heat or Steam Sterilization

[00190376477398]

Moist Heat or Steam Sterilization

[00190376477398]

Moist Heat or Steam Sterilization

[00190376477398]

Moist Heat or Steam Sterilization

[00190376477398]

Moist Heat or Steam Sterilization

[00190376477398]

Moist Heat or Steam Sterilization

[00190376477398]

Moist Heat or Steam Sterilization

[00190376477398]

Moist Heat or Steam Sterilization

[00190376477398]

Moist Heat or Steam Sterilization

[00190376477398]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-05
• Device Publish Date: 2024-10-28

On-Brand Devices [Ascend]

• 00190376544892: Ascend TL VBR Instruments A
• 00190376544885: Ascend TL VBR Instruments B
• 00190376523576: TL VBR DISTRACTOR HANDLE
• 00190376523316: 16 mm STATIC CORE, 26 mm
• 00190376523309: 16 mm STATIC CORE, 22 mm
• 00190376523293: 16 mm STATIC CORE, 18 mm
• 00190376522012: TL VBR 16 mm CORE REMOVAL TOOL
• 00190376521572: 16 mm CORE ENDPLATE, BAN 18 x 50 mm 10°
• 00190376521565: 16 mm CORE ENDPLATE, BAN 18 x 50 mm 5°
• 00190376521558: 16 mm CORE ENDPLATE, BAN 18 x 50 mm 0°
• 00190376521541: 16 mm CORE ENDPLATE, BAN 18 x 45 mm 10°
• 00190376521534: 16 mm CORE ENDPLATE, BAN 18 x 45 mm 5°
• 00190376521527: 16 mm CORE ENDPLATE, BAN 18 x 45 mm 0°
• 00190376521473: 16 mm CORE ENDPLATE, BAN 18 x 40 mm 10°
• 00190376521466: 16 mm CORE ENDPLATE, BAN 18 x 40 mm 5°
• 00190376521459: 16 mm CORE ENDPLATE, BAN 18 x 40 mm 0°
• 00190376521442: 16 mm CORE ENDPLATE, BAN 18 x 35 mm 10°
• 00190376521435: 16 mm CORE ENDPLATE, BAN 18 x 35 mm 5°
• 00190376521428: 16 mm CORE ENDPLATE, BAN 18 x 35 mm 0°
• 00190376521411: 16 mm CORE ENDPLATE, BAN 18 x 30 mm 10°
• 00190376521404: 16 mm CORE ENDPLATE, BAN 18 x 30 mm 5°
• 00190376521398: 16 mm CORE ENDPLATE, BAN 18 x 30 mm 0°
• 00190376521381: 16 mm CORE ENDPLATE, BAN 18 x 25 mm 10°
• 00190376521367: 16 mm CORE ENDPLATE, BAN 18 x 25 mm 0°
• 00190376521350: 16 mm CORE ENDPLATE, BAN 16 x 50 mm 10°
• 00190376521343: 16 mm CORE ENDPLATE, BAN 16 x 50 mm 5°
• 00190376521336: 16 mm CORE ENDPLATE, BAN 16 x 50 mm 0°
• 00190376521329: 16 mm CORE ENDPLATE, BAN 16 x 45 mm 10°
• 00190376521312: 16 mm CORE ENDPLATE, BAN 16 x 45 mm 5°
• 00190376521305: 16 mm CORE ENDPLATE, BAN 16 x 45 mm 0°
• 00190376521299: 16 mm CORE ENDPLATE, BAN 16 x 40 mm 10°
• 00190376521282: 16 mm CORE ENDPLATE, BAN 16 x 40 mm 5°
• 00190376521275: 16 mm CORE ENDPLATE, BAN 16 x 40 mm 0°
• 00190376521268: 16 mm CORE ENDPLATE, BAN 16 x 35 mm 10°
• 00190376521251: 16 mm CORE ENDPLATE, BAN 16 x 35 mm 5°
• 00190376521244: 16 mm CORE ENDPLATE, BAN 16 x 35 mm 0°
• 00190376521237: 16 mm CORE ENDPLATE, BAN 16 x 30 mm 10°
• 00190376521220: 16 mm CORE ENDPLATE, BAN 16 x 30 mm 5°
• 00190376521213: 16 mm CORE ENDPLATE, BAN 16 x 30 mm 0°
• 00190376521206: 16 mm CORE ENDPLATE, BAN 16 x 25 mm 10°
• 00190376521190: 16 mm CORE ENDPLATE, BAN 16 x 25 mm 5°
• 00190376521183: 16 mm CORE ENDPLATE, BAN 16 x 25 mm 0°
• 00190376520896: 16 mm CORE ENDPLATE, LAT 22 x 60 mm 10°
• 00190376520889: 16 mm CORE ENDPLATE, LAT 22 x 60 mm 5°
• 00190376520872: 16 mm CORE ENDPLATE, LAT 22 x 60 mm 0°
• 00190376520865: 16 mm CORE ENDPLATE, LAT 22 x 55 mm 10°
• 00190376520858: 16 mm CORE ENDPLATE, LAT 22 x 55 mm 5°
• 00190376520841: 16 mm CORE ENDPLATE, LAT 22 x 55 mm 0°
• 00190376520834: 16 mm CORE ENDPLATE, LAT 22 x 50 mm 10°
• 00190376520810: 16 mm CORE ENDPLATE, LAT 22 x 50 mm 0°