Pegasus Anchored Cervical Interbody System

GUDID 00840967123486

Pegasus Inserter

ALPHATEC SPINE, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00840967123486
• NIH Device Record Key: 0be0e859-91ca-4762-8624-100914a79933
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pegasus Anchored Cervical Interbody System
• Version Model Number: 22930
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840967123486 [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

[00840967123486]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-14

Devices Manufactured by ALPHATEC SPINE, INC.

• 00190376517506 - SafeOp 3: 2024-11-20 SafeOp 3 Patient Interface
• 00190376530024 - SafeOp 3: 2024-11-20 Patient Interface Power Supply
• 00190376537108 - SafeOp 3: 2024-11-20 SafeOp 3 Electrode Kit – EMG Only - Needle
• 00190376537115 - SafeOp 3: 2024-11-20 SafeOp 3 Electrode Kit – EMG Only - Surface
• 00190376537122 - SafeOp 3: 2024-11-20 SafeOp 3 Cervical Electrode Kit – EMG/SSEP - Needle
• 00190376537139 - SafeOp 3: 2024-11-20 SafeOp 3 Cervical Electrode Kit - EMG/SSEP - Surface
• 00190376537146 - SafeOp 3: 2024-11-20 SafeOp 3 PTP/LTP Electrode Kit - EMG/SSEP - Needle
• 00190376537153 - SafeOp 3: 2024-11-20 SafeOp 3 PTP/LTP Electrode Kit - EMG/SSEP - Surface