CoFix Implant 8 mm RQI00008

GUDID 04260148898235

Paradigm Spine, LLC

Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant

• Primary Device ID: 04260148898235
• NIH Device Record Key: 4e272bc2-eab7-4c73-9c43-6cf19723b525
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoFix Implant 8 mm
• Version Model Number: RQI00008
• Catalog Number: RQI00008
• Company DUNS: 787874960
• Company Name: Paradigm Spine, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260148898235 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153302

FDA Product Code

• PEK: Spinous Process Plate

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-27
• Device Publish Date: 2020-03-19

Devices Manufactured by Paradigm Spine, LLC

• 04260148898235 - CoFix Implant 8 mm: 2020-03-27
• 04260148898235 - CoFix Implant 8 mm: 2020-03-27
• 04260148898242 - CoFix Implant 10 mm: 2020-03-27
• 04260148898259 - CoFix Implant 12 mm: 2020-03-27
• 04260148898266 - CoFix Implant 14 mm: 2020-03-27
• 04260148898273 - CoFix Implant 16 mm: 2020-03-27
• 04260148897931 - CoFix Sterilization Tray: 2020-03-12
• 04260636670459 - coflex-F LIS screw inserter: 2020-03-12
• 04260148896927 - DSS HP Polyaxial pedicle screw set, Ø5 x 45mm: 2019-09-26