Pegasus

GUDID 00811801032554

Pegasus Inserter - Impaction Option

ALPHATEC SPINE, INC.

Orthopaedic inorganic implant inserter/extractor, reusable

• Primary Device ID: 00811801032554
• NIH Device Record Key: 1e30b51f-cccc-4396-a0cb-bf8db84f8232
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pegasus
• Version Model Number: CI-10108
• Company DUNS: 602465783
• Company Name: ALPHATEC SPINE, INC.
• Device Count: 1
• DM Exempt: false
• 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: 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
• 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	00811801032554 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150913

FDA Product Code

• OVE: Intervertebral fusion device with integrated fixation, cervical

Sterilization

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

[00811801032554]

Moist Heat or Steam Sterilization

[00811801032554]

Moist Heat or Steam Sterilization

[00811801032554]

Moist Heat or Steam Sterilization

[00811801032554]

Moist Heat or Steam Sterilization

[00811801032554]

Moist Heat or Steam Sterilization

[00811801032554]

Moist Heat or Steam Sterilization

[00811801032554]

Moist Heat or Steam Sterilization

[00811801032554]

Moist Heat or Steam Sterilization

[00811801032554]

Moist Heat or Steam Sterilization

[00811801032554]

Moist Heat or Steam Sterilization

[00811801032554]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-09-11
• Device Publish Date: 2020-09-19

On-Brand Devices [Pegasus]

• 00190376276175: Pegasus Anchored Cervical IB Fusion Device 2.0
• 00811801032554: Pegasus Inserter - Impaction Option