CORTICAL LOCKING SCREW 3.5mm x 12mm

GUDID 00848665007800

ADVANCED ORTHOPEDIC SOLUTIONS INC

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00848665007800
• NIH Device Record Key: 187506ab-d66b-45d2-b29c-0743f35d06a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CORTICAL LOCKING SCREW 3.5mm x 12mm
• Version Model Number: 8014-120
• 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	00848665007800 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080590

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00848665007800]

Moist Heat or Steam Sterilization

[00848665007800]

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 12mm]

• 00848665007800: 8014-120
• 00848665007565: 8012-120