Avalon

GUDID 00840967193137

4.5mm STRAIGHT TAP

ALPHATEC SPINE, INC.

Bone tap, reusable

• Primary Device ID: 00840967193137
• NIH Device Record Key: 2c856661-0214-4c1b-84b8-0ab648741146
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Avalon
• Version Model Number: 75006
• Company DUNS: 602465783
• Company Name: ALPHATEC SPINE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840967193137 [Primary]

FDA Product Code

• HWX: TAP, BONE

Sterilization

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

[00840967193137]

Moist Heat or Steam Sterilization

[00840967193137]

Moist Heat or Steam Sterilization

[00840967193137]

Moist Heat or Steam Sterilization

[00840967193137]

Moist Heat or Steam Sterilization

[00840967193137]

Moist Heat or Steam Sterilization

[00840967193137]

Moist Heat or Steam Sterilization

[00840967193137]

Moist Heat or Steam Sterilization

[00840967193137]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-12-08
• Device Publish Date: 2020-06-17

On-Brand Devices [Avalon]

• 00190376275246: Avalon Occipito-Cervico-Thoracic Fixation System
• 00840967193212: OCCIPITAL PLATE HOLDER
• 00840967193168: 4.5mm FLEXIBLE TAP
• 00840967193137: 4.5mm STRAIGHT TAP
• 00840967193267: OCCIPITAL PLATE ROTATING BODY ADJUSTMENT TOOL
• 00840967193229: OCCIPITAL PLATE BENDER
• 00840967193205: OCCIPITAL PLATE ROD BENDER, 3.3-4.0mm
• 00840967193199: IN SITU ROD BENDER, RIGHT
• 00840967193182: IN SITU ROD BENDER, LEFT