AOS CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 35mm

GUDID 00848665012828

ADVANCED ORTHOPEDIC SOLUTIONS INC

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

• Primary Device ID: 00848665012828
• NIH Device Record Key: 103e7ec4-982e-4e7c-b9f9-1f8ecd8145eb
• Commercial Distribution Discontinuation: 2017-06-14
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: AOS CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 35mm
• Version Model Number: S8060-035
• 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	00848665012828 [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: 2016-01-19

On-Brand Devices [AOS CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 35mm]

• 00848665023077: S8065-035
• 00848665022858: 8065-035
• 00848665020724: 8060-035
• 00848665012828: S8060-035