Screw 3.5mm x 44mm 8100-044

GUDID 00848665037128

ADVANCED ORTHOPEDIC SOLUTIONS INC

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00848665037128
• NIH Device Record Key: f62a9ecc-cfde-405c-affc-e06093d81564
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Screw 3.5mm x 44mm
• Version Model Number: 8100-044
• Catalog Number: 8100-044
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 310-533-9966
• Email: regaffairs@aosortho.com
• Phone: (310) 533-9966
• Email: regaffairs@aosortho.com
• Phone: (310) 533-9966
• Email: regaffairs@aosortho.com
• Phone: (310) 533-9966
• Email: regaffairs@aosortho.com
• Phone: (310) 533-9966
• Email: regaffairs@aosortho.com
• Phone: (310) 533-9966
• Email: regaffairs@aosortho.com
• Phone: (310) 533-9966
• Email: regaffairs@aosortho.com
• Phone: (310) 533-9966
• Email: regaffairs@aosortho.com
• Phone: (310) 533-9966
• Email: regaffairs@aosortho.com
• Phone: (310) 533-9966
• Email: regaffairs@aosortho.com
• Phone: (310) 533-9966
• Email: regaffairs@aosortho.com
• Phone: (310) 533-9966
• Email: regaffairs@aosortho.com
• Phone: (310) 533-9966
• Email: regaffairs@aosortho.com
• Phone: (310) 533-9966
• Email: regaffairs@aosortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848665037128 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152732
• Premarket Notification: K182466

FDA Product Code

• HRS: Plate, Fixation, Bone
• HWC: Screw, Fixation, Bone

Sterilization

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

[00848665037128]

Moist Heat or Steam Sterilization

[00848665037128]

Moist Heat or Steam Sterilization

[00848665037128]

Moist Heat or Steam Sterilization

[00848665037128]

Moist Heat or Steam Sterilization

[00848665037128]

Moist Heat or Steam Sterilization

[00848665037128]

Moist Heat or Steam Sterilization

[00848665037128]

Moist Heat or Steam Sterilization

[00848665037128]

Moist Heat or Steam Sterilization

[00848665037128]

Moist Heat or Steam Sterilization

[00848665037128]

Moist Heat or Steam Sterilization

[00848665037128]

Moist Heat or Steam Sterilization

[00848665037128]

Moist Heat or Steam Sterilization

[00848665037128]

Moist Heat or Steam Sterilization

[00848665037128]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-19
• Device Publish Date: 2020-02-11

Devices Manufactured by ADVANCED ORTHOPEDIC SOLUTIONS INC

• 00848665027679 - COUNTERSINK: 2020-06-23
• 00848665000658 - AOS Drill, AO Style, 2.9mm x 100mm: 2020-06-08
• 00848665001235 - AOS CANCELLOUS TAP 3.5mm: 2020-06-08
• 00848665027624 - SUPRAPATELLAR TIBIAL ENTRY SHEATH: 2020-06-08
• 00848665028041 - T10 Screwdriver, Short: 2020-06-08
• 00848665028096 - 3.5mm Calibrated Drill: 2020-06-08
• 00848665028119 - AOS 2.6mm Solid Reamer: 2020-06-08
• 00848665028782 - T10 Screwdriver, Solid: 2020-06-08