coflex-F™ System 14mm

GUDID 04260148897504

Paradigm Spine, LLC

Lumbar interspinous decompression spacer, sterile Lumbar interspinous decompression spacer, sterile Lumbar interspinous decompression spacer, sterile Lumbar interspinous decompression spacer, sterile Lumbar interspinous decompression spacer, sterile Lumbar interspinous decompression spacer, sterile Lumbar interspinous decompression spacer, sterile Lumbar interspinous decompression spacer, sterile Lumbar interspinous decompression spacer, sterile Lumbar interspinous decompression spacer, sterile Lumbar interspinous decompression spacer, sterile Lumbar interspinous decompression spacer, sterile Lumbar interspinous decompression spacer, sterile Lumbar interspinous decompression spacer, sterile Lumbar interspinous decompression spacer, sterile Lumbar interspinous decompression spacer, sterile Lumbar interspinous decompression spacer, sterile Lumbar interspinous decompression spacer, sterile Lumbar interspinous decompression spacer, sterile Lumbar interspinous decompression spacer, sterile Lumbar interspinous decompression spacer, sterile Lumbar interspinous decompression spacer, sterile Lumbar interspinous decompression spacer, sterile Lumbar interspinous decompression spacer, sterile Lumbar interspinous decompression spacer, sterile Lumbar interspinous decompression spacer, sterile Lumbar interspinous decompression spacer, sterile Lumbar interspinous decompression spacer, sterile Lumbar interspinous decompression spacer, sterile Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer

• Primary Device ID: 04260148897504
• NIH Device Record Key: 7663322c-53a4-4e5e-9eb0-3cd2b5409de7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: coflex-F™ System 14mm
• Version Model Number: RPI00014
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	04260148897504 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093438

FDA Product Code

• KWP: Appliance, Fixation, Spinal Interlaminal

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: 2018-07-06
• Device Publish Date: 2015-10-01

Devices Manufactured by Paradigm Spine, LLC

• 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