Conventus Cage - PR, Large

GUDID 00814289020761

CONVENTUS ORTHOPAEDICS, INC.

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

• Primary Device ID: 00814289020761
• NIH Device Record Key: 5dd78046-2472-48b5-a3b2-723802c67dc1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Conventus Cage - PR, Large
• Version Model Number: PR-L
• Company DUNS: 021231299
• Company Name: CONVENTUS ORTHOPAEDICS, INC.
• 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	00814289020761 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151379

FDA Product Code

• HSB: Rod, Fixation, Intramedullary And Accessories

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: 2015-12-31

Devices Manufactured by CONVENTUS ORTHOPAEDICS, INC.

• 00814289020754 - Conventus Cage - PR, Small: 2018-07-06
• 00814289020761 - Conventus Cage - PR, Large: 2018-07-06
• 00814289020761 - Conventus Cage - PR, Large: 2018-07-06
• 00814289020006 - Conventus Cage - DR, Small: 2018-03-29
• 00814289020013 - Conventus Cage - DR, Large: 2018-03-29
• 00814289020020 - 2.7mm x 8mm Cannulated Headed Screw: 2018-03-29
• 00814289020037 - 2.7mm x 10mm Cannulated Headed Screw: 2018-03-29
• 00814289020044 - 2.7mm x 12mm Cannulated Headed Screw: 2018-03-29
• 00814289020051 - 2.7mm x 14mm Cannulated Headed Screw: 2018-03-29