PROXIMAL TIBIAL INSTRUMENT TRAY

GUDID 00848665032147

ADVANCED ORTHOPAEDIC SOLUTIONS, INC.

Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack

• Primary Device ID: 00848665032147
• NIH Device Record Key: 0b51eaa3-cd79-44f1-86ca-dcce027a4896
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROXIMAL TIBIAL INSTRUMENT TRAY
• Version Model Number: 9956-100
• Company DUNS: 117858154
• Company Name: ADVANCED ORTHOPAEDIC 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: false
• 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: ATI_Regulatory@arthrex.com
• Phone: (310) 533-9966
• Email: ATI_Regulatory@arthrex.com
• Phone: (310) 533-9966
• Email: ATI_Regulatory@arthrex.com
• Phone: (310) 533-9966
• Email: ATI_Regulatory@arthrex.com
• Phone: (310) 533-9966
• Email: ATI_Regulatory@arthrex.com
• Phone: (310) 533-9966
• Email: ATI_Regulatory@arthrex.com
• Phone: (310) 533-9966
• Email: ATI_Regulatory@arthrex.com
• Phone: (310) 533-9966
• Email: ATI_Regulatory@arthrex.com
• Phone: (310) 533-9966
• Email: ATI_Regulatory@arthrex.com
• Phone: (310) 533-9966
• Email: ATI_Regulatory@arthrex.com
• Phone: (310) 533-9966
• Email: ATI_Regulatory@arthrex.com
• Phone: (310) 533-9966
• Email: ATI_Regulatory@arthrex.com
• Phone: (310) 533-9966
• Email: ATI_Regulatory@arthrex.com
• Phone: (310) 533-9966
• Email: ATI_Regulatory@arthrex.com
• Phone: (310) 533-9966
• Email: ATI_Regulatory@arthrex.com
• Phone: (310) 533-9966
• Email: ATI_Regulatory@arthrex.com
• Phone: (310) 533-9966
• Email: ATI_Regulatory@arthrex.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848665032147 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202489

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[00848665032147]

Moist Heat or Steam Sterilization

[00848665032147]

Moist Heat or Steam Sterilization

[00848665032147]

Moist Heat or Steam Sterilization

[00848665032147]

Moist Heat or Steam Sterilization

[00848665032147]

Moist Heat or Steam Sterilization

[00848665032147]

Moist Heat or Steam Sterilization

[00848665032147]

Moist Heat or Steam Sterilization

[00848665032147]

Moist Heat or Steam Sterilization

[00848665032147]

Moist Heat or Steam Sterilization

[00848665032147]

Moist Heat or Steam Sterilization

[00848665032147]

Moist Heat or Steam Sterilization

[00848665032147]

Moist Heat or Steam Sterilization

[00848665032147]

Moist Heat or Steam Sterilization

[00848665032147]

Moist Heat or Steam Sterilization

[00848665032147]

Moist Heat or Steam Sterilization

[00848665032147]

Moist Heat or Steam Sterilization

[00848665032147]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-18
• Device Publish Date: 2022-02-10

Devices Manufactured by ADVANCED ORTHOPAEDIC SOLUTIONS, INC.

• 00848665032703 - MINIMALLY INVASIVE CALCANEAL PLATE, LEFT, SMALL: 2024-02-19
• 00848665032710 - MINIMALLY INVASIVE CALCANEAL PLATE, LEFT, MEDIUM: 2024-02-19
• 00848665032727 - MINIMALLY INVASIVE CALCANEAL PLATE, LEFT, LARGE: 2024-02-19
• 00848665032734 - MINIMALLY INVASIVE CALCANEAL PLATE, RIGHT,SMALL: 2024-02-19
• 00848665032741 - MINIMALLY INVASIVE CALCANEAL PLATE, RIGHT, MEDIUM: 2024-02-19
• 00848665032758 - MINIMALLY INVASIVE CALCANEAL PLATE, RIGHT, LARGE: 2024-02-19
• 00848665034066 - BENDING TEMPLATE,MINIMALLY INVASIVE CALCANEAL PLATE, EXTRA SMALL: 2024-02-19
• 00848665035988 - VARIABLE ANGLE LOCKING SCREW, 3.5mm x 95mm: 2024-02-19