WORKHORSE SCREW, T10, NON-LOCKING 3.5mm x 16mm

GUDID 00848665036985

ADVANCED ORTHOPEDIC SOLUTIONS INC

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00848665036985
• NIH Device Record Key: c8c45b8b-f062-43f7-baac-2d0189a1b1c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WORKHORSE SCREW, T10, NON-LOCKING 3.5mm x 16mm
• Version Model Number: 8100-016
• 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: 3105339966
• 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
• Phone: (310) 533-9966
• Email: regaffairs@aosortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848665036985 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152732
• Premarket Notification: K161913

FDA Product Code

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

Sterilization

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

[00848665036985]

Moist Heat or Steam Sterilization

[00848665036985]

Moist Heat or Steam Sterilization

[00848665036985]

Moist Heat or Steam Sterilization

[00848665036985]

Moist Heat or Steam Sterilization

[00848665036985]

Moist Heat or Steam Sterilization

[00848665036985]

Moist Heat or Steam Sterilization

[00848665036985]

Moist Heat or Steam Sterilization

[00848665036985]

Moist Heat or Steam Sterilization

[00848665036985]

Moist Heat or Steam Sterilization

[00848665036985]

Moist Heat or Steam Sterilization

[00848665036985]

Moist Heat or Steam Sterilization

[00848665036985]

Moist Heat or Steam Sterilization

[00848665036985]

Moist Heat or Steam Sterilization

[00848665036985]

Moist Heat or Steam Sterilization

[00848665036985]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-24
• Device Publish Date: 2020-04-16

On-Brand Devices [WORKHORSE SCREW, T10, NON-LOCKING 3.5mm x 16mm]

• 00848665036992: 8100-018
• 00848665036985: 8100-016