AOS ANTI-ROTATION SCREW 5.0mm x 85mm

GUDID 00848665008197

ADVANCED ORTHOPEDIC SOLUTIONS INC

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00848665008197
• NIH Device Record Key: b3653723-a8ea-4f55-9824-d485e5e0badf
• Commercial Distribution Discontinuation: 2017-06-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: AOS ANTI-ROTATION SCREW 5.0mm x 85mm
• Version Model Number: S8021-085
• 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	00848665008197 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021008

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 ANTI-ROTATION SCREW 5.0mm x 85mm]

• 00848665019896: 8021-085
• 00848665008197: S8021-085