SCREW SHEATH

GUDID 00848665032161

ADVANCED ORTHOPAEDIC SOLUTIONS, INC.

Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable

• Primary Device ID: 00848665032161
• NIH Device Record Key: e51ab49d-b8ce-4d5c-9d2f-60bcd274ac97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCREW SHEATH
• Version Model Number: 0601-100
• 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	00848665032161 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050241

FDA Product Code

• HSB: Rod, Fixation, Intramedullary And Accessories

Sterilization

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

[00848665032161]

Moist Heat or Steam Sterilization

[00848665032161]

Moist Heat or Steam Sterilization

[00848665032161]

Moist Heat or Steam Sterilization

[00848665032161]

Moist Heat or Steam Sterilization

[00848665032161]

Moist Heat or Steam Sterilization

[00848665032161]

Moist Heat or Steam Sterilization

[00848665032161]

Moist Heat or Steam Sterilization

[00848665032161]

Moist Heat or Steam Sterilization

[00848665032161]

Moist Heat or Steam Sterilization

[00848665032161]

Moist Heat or Steam Sterilization

[00848665032161]

Moist Heat or Steam Sterilization

[00848665032161]

Moist Heat or Steam Sterilization

[00848665032161]

Moist Heat or Steam Sterilization

[00848665032161]

Moist Heat or Steam Sterilization

[00848665032161]

Moist Heat or Steam Sterilization

[00848665032161]

Moist Heat or Steam Sterilization

[00848665032161]

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