MAGEC® Spinal Bracing and Distraction System PA0684-011

GUDID 00812258022655

Spinal bracing and distraction system, 5.5 mm offset rod with 70 mm actuator

NUVASIVE SPECIALIZED ORTHOPEDICS, INC.

Trans-facet-screw internal spinal fixation system, sterile

• Primary Device ID: 00812258022655
• NIH Device Record Key: d2bb8b43-13a9-4b07-940b-46c33df2de7a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAGEC® Spinal Bracing and Distraction System
• Version Model Number: MC2-5570R
• Catalog Number: PA0684-011
• Company DUNS: 837845234
• Company Name: NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: 855-435-5477
• Email: csdepartment@ellipse-tech.com
• Phone: 855-435-5477
• Email: csdepartment@ellipse-tech.com

Device Dimensions

• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812258022655 [Primary]

FDA Product Code

• PGN: Growing Rod System- Magnetic Actuation

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-04-25
• Device Publish Date: 2016-01-15

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