Continuum

GUDID 00850039803017

ACDF IMPLANT KIT - 16X12MM ANGLED

Pressio, Inc

Memory-alloy orthopaedic fixation plate Memory-alloy orthopaedic fixation plate Memory-alloy orthopaedic fixation plate Memory-alloy orthopaedic fixation plate Memory-alloy orthopaedic fixation plate Memory-alloy orthopaedic fixation plate Memory-alloy orthopaedic fixation plate Memory-alloy orthopaedic fixation plate Memory-alloy orthopaedic fixation plate Memory-alloy orthopaedic fixation plate Memory-alloy orthopaedic fixation plate Memory-alloy orthopaedic fixation plate Memory-alloy orthopaedic fixation plate Memory-alloy orthopaedic fixation plate Memory-alloy orthopaedic fixation plate Memory-alloy orthopaedic fixation plate Memory-alloy orthopaedic fixation plate

• Primary Device ID: 00850039803017
• NIH Device Record Key: b487c1a5-0104-4f59-a269-6e85bdc98ac8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Continuum
• Version Model Number: PS-01-1612A
• Company DUNS: 084706556
• Company Name: Pressio, 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850039803017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200301

FDA Product Code

• PHQ: Anterior Staple As Supplemental Fixation For Fusion

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: 2023-05-09
• Device Publish Date: 2023-05-01

On-Brand Devices [Continuum]

• 00850039803079: ACDF IMPLANT KIT - 20X12MM STRAIGHT
• 00850039803062: ACDF IMPLANT KIT - 18X12MM STRAIGHT
• 00850039803055: ACDF IMPLANT KIT - 16X12MM STRAIGHT
• 00850039803048: ACDF IMPLANT KIT - 14X12MM STRAIGHT
• 00850039803031: ACDF IMPLANT KIT - 20X12MM ANGLED
• 00850039803024: ACDF IMPLANT KIT - 18X12MM ANGLED
• 00850039803017: ACDF IMPLANT KIT - 16X12MM ANGLED
• 00850039803000: ACDF IMPLANT KIT - 14X12MM ANGLED