coflex-F™ System 16mm

GUDID 04260148897511

Paradigm Spine, LLC

Lumbar interspinous decompression spacer, sterile

• Primary Device ID: 04260148897511
• NIH Device Record Key: bc250343-d22a-4baf-bb8f-35b7d4237176
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: coflex-F™ System 16mm
• Version Model Number: RPI00016
• 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	04260148897511 [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