CORTICAL LOCKING SCREW 3.5mm x 8mm

GUDID 00848665007541

ADVANCED ORTHOPEDIC SOLUTIONS INC

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00848665007541
• NIH Device Record Key: 4e608642-3c5d-430d-9cbc-dae733c95edb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CORTICAL LOCKING SCREW 3.5mm x 8mm
• Version Model Number: 8012-080
• 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	00848665007541 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080590

FDA Product Code

• KTW: Appliance, Fixation, Nail/Blade/Plate Combination, Single Component

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00848665007541]

Moist Heat or Steam Sterilization

[00848665007541]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-12-22

On-Brand Devices [CORTICAL LOCKING SCREW 3.5mm x 8mm]

• 00848665007787: 8014-080
• 00848665007541: 8012-080