coflex Interlaminar Technology, 8mm

GUDID 04260148898457

Paradigm Spine, LLC

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable

• Primary Device ID: 04260148898457
• NIH Device Record Key: 33896ca6-913b-4cf9-ac40-29baf192ce76
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: coflex Interlaminar Technology, 8mm
• Version Model Number: UPI00008
• 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	04260148898457 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P110008

FDA Product Code

• NQO: Prosthesis, Spinous Process Spacer/Plate

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: 2014-07-28

On-Brand Devices [coflex Interlaminar Technology, 8mm]

• 04260148898501: UQI00008
• 04260148898457: UPI00008