AOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 45mm

GUDID 00848665012613

ADVANCED ORTHOPEDIC SOLUTIONS INC

Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00848665012613
• NIH Device Record Key: f46c44ee-709d-4f6f-8e0f-0341599e2cda
• Commercial Distribution Discontinuation: 2017-06-14
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: AOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 45mm
• Version Model Number: S8059-045
• Company DUNS: 117858154
• Company Name: ADVANCED ORTHOPEDIC SOLUTIONS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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	00848665012613 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132005

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: 2016-01-18

On-Brand Devices [AOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 45mm]

• 00848665020519: 8059-045
• 00848665012613: S8059-045