3.5mm Cortical Screw, 26mm TO-35-CS-26

GUDID 00816101010134

The titanium alloy cortical screws are used to affix the plate to the humerus. The screws are 3.5mm diameter and are available in various lengths from 20mm to 34mm.

TOBY ORTHOPAEDICS

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00816101010134
• NIH Device Record Key: d850b0d2-b663-41d1-91e0-c0cbe2f90f83
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3.5mm Cortical Screw, 26mm
• Version Model Number: NA
• Catalog Number: TO-35-CS-26
• Company DUNS: 024163331
• Company Name: TOBY ORTHOPAEDICS
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 305-665-8699
• Email: sales@tobyortho.com
• Phone: 305-665-8699
• Email: sales@tobyortho.com
• Phone: 305-665-8699
• Email: sales@tobyortho.com
• Phone: 305-665-8699
• Email: sales@tobyortho.com
• Phone: 305-665-8699
• Email: sales@tobyortho.com
• Phone: 305-665-8699
• Email: sales@tobyortho.com
• Phone: 305-665-8699
• Email: sales@tobyortho.com
• Phone: 305-665-8699
• Email: sales@tobyortho.com
• Phone: 305-665-8699
• Email: sales@tobyortho.com
• Phone: 305-665-8699
• Email: sales@tobyortho.com
• Phone: 305-665-8699
• Email: sales@tobyortho.com
• Phone: 305-665-8699
• Email: sales@tobyortho.com
• Phone: 305-665-8699
• Email: sales@tobyortho.com
• Phone: 305-665-8699
• Email: sales@tobyortho.com
• Phone: 305-665-8699
• Email: sales@tobyortho.com
• Phone: 305-665-8699
• Email: sales@tobyortho.com
• Phone: 305-665-8699
• Email: sales@tobyortho.com
• Phone: 305-665-8699
• Email: sales@tobyortho.com
• Phone: 305-665-8699
• Email: sales@tobyortho.com
• Phone: 305-665-8699
• Email: sales@tobyortho.com
• Phone: 305-665-8699
• Email: sales@tobyortho.com
• Phone: 305-665-8699
• Email: sales@tobyortho.com
• Phone: 305-665-8699
• Email: sales@tobyortho.com
• Phone: 305-665-8699
• Email: sales@tobyortho.com
• Phone: 305-665-8699
• Email: sales@tobyortho.com
• Phone: 305-665-8699
• Email: sales@tobyortho.com
• Phone: 305-665-8699
• Email: sales@tobyortho.com
• Phone: 305-665-8699
• Email: sales@tobyortho.com
• Phone: 305-665-8699
• Email: sales@tobyortho.com
• Phone: 305-665-8699
• Email: sales@tobyortho.com
• Phone: 305-665-8699
• Email: sales@tobyortho.com
• Phone: 305-665-8699
• Email: sales@tobyortho.com
• Phone: 305-665-8699
• Email: sales@tobyortho.com
• Phone: 305-665-8699
• Email: sales@tobyortho.com
• Phone: 305-665-8699
• Email: sales@tobyortho.com
• Phone: 305-665-8699
• Email: sales@tobyortho.com
• Phone: 305-665-8699
• Email: sales@tobyortho.com
• Phone: 305-665-8699
• Email: sales@tobyortho.com
• Phone: 305-665-8699
• Email: sales@tobyortho.com
• Phone: 305-665-8699
• Email: sales@tobyortho.com
• Phone: 305-665-8699
• Email: sales@tobyortho.com
• Phone: 305-665-8699
• Email: sales@tobyortho.com
• Phone: 305-665-8699
• Email: sales@tobyortho.com
• Phone: 305-665-8699
• Email: sales@tobyortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816101010134 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081608

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00816101010134]

Moist Heat or Steam Sterilization

[00816101010134]

Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

[00816101010134]

Moist Heat or Steam Sterilization

[00816101010134]

Moist Heat or Steam Sterilization

[00816101010134]

Moist Heat or Steam Sterilization

[00816101010134]

Moist Heat or Steam Sterilization

[00816101010134]

Moist Heat or Steam Sterilization

[00816101010134]

Moist Heat or Steam Sterilization

[00816101010134]

Moist Heat or Steam Sterilization

[00816101010134]

Moist Heat or Steam Sterilization

[00816101010134]

Moist Heat or Steam Sterilization

[00816101010134]

Moist Heat or Steam Sterilization

[00816101010134]

Moist Heat or Steam Sterilization

[00816101010134]

Moist Heat or Steam Sterilization

[00816101010134]

Moist Heat or Steam Sterilization

[00816101010134]

Moist Heat or Steam Sterilization

[00816101010134]

Moist Heat or Steam Sterilization

[00816101010134]

Moist Heat or Steam Sterilization

[00816101010134]

Moist Heat or Steam Sterilization

[00816101010134]

Moist Heat or Steam Sterilization

[00816101010134]

Moist Heat or Steam Sterilization

[00816101010134]

Moist Heat or Steam Sterilization

[00816101010134]

Moist Heat or Steam Sterilization

[00816101010134]

Moist Heat or Steam Sterilization

[00816101010134]

Moist Heat or Steam Sterilization

[00816101010134]

Moist Heat or Steam Sterilization

[00816101010134]

Moist Heat or Steam Sterilization

[00816101010134]

Moist Heat or Steam Sterilization

[00816101010134]

Moist Heat or Steam Sterilization

[00816101010134]

Moist Heat or Steam Sterilization

[00816101010134]

Moist Heat or Steam Sterilization

[00816101010134]

Moist Heat or Steam Sterilization

[00816101010134]

Moist Heat or Steam Sterilization

[00816101010134]

Moist Heat or Steam Sterilization

[00816101010134]

Moist Heat or Steam Sterilization

[00816101010134]

Moist Heat or Steam Sterilization

[00816101010134]

Moist Heat or Steam Sterilization

[00816101010134]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-17
• Device Publish Date: 2020-08-09

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