Orthex External Fixation System R025-205-BLUE

GUDID 00840194408141

Orthex Toe Ring 205mm, Blue

ORTHOPEDIATRICS CORP.

External orthopaedic fixation system, single-use

• Primary Device ID: 00840194408141
• NIH Device Record Key: 60e9e1e5-a9ec-4655-a455-32ba7224b777
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orthex External Fixation System
• Version Model Number: R025-205-BLUE
• Catalog Number: R025-205-BLUE
• Company DUNS: 796416191
• Company Name: ORTHOPEDIATRICS CORP.
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(574)268-6379
• Email: yli@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: yli@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: yli@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: yli@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: yli@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: yli@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: yli@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: yli@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: yli@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: yli@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: yli@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: yli@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: yli@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: yli@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: yli@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: yli@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: yli@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: yli@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: yli@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: yli@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: yli@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: yli@orthopediatrics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840194408141 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151881

FDA Product Code

• KTT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

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

[00840194408141]

Moist Heat or Steam Sterilization

[00840194408141]

Moist Heat or Steam Sterilization

[00840194408141]

Moist Heat or Steam Sterilization

[00840194408141]

Moist Heat or Steam Sterilization

[00840194408141]

Moist Heat or Steam Sterilization

[00840194408141]

Moist Heat or Steam Sterilization

[00840194408141]

Moist Heat or Steam Sterilization

[00840194408141]

Moist Heat or Steam Sterilization

[00840194408141]

Moist Heat or Steam Sterilization

[00840194408141]

Moist Heat or Steam Sterilization

[00840194408141]

Moist Heat or Steam Sterilization

[00840194408141]

Moist Heat or Steam Sterilization

[00840194408141]

Moist Heat or Steam Sterilization

[00840194408141]

Moist Heat or Steam Sterilization

[00840194408141]

Moist Heat or Steam Sterilization

[00840194408141]

Moist Heat or Steam Sterilization

[00840194408141]

Moist Heat or Steam Sterilization

[00840194408141]

Moist Heat or Steam Sterilization

[00840194408141]

Moist Heat or Steam Sterilization

[00840194408141]

Moist Heat or Steam Sterilization

[00840194408141]

Moist Heat or Steam Sterilization

[00840194408141]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-25
• Device Publish Date: 2022-07-15

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• 00840194410755: Orthex FootPlate 180mm Short, Orange
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• 00840194410731: Orthex FootPlate 180mm Short, Red
• 00840194410724: Orthex FootPlate 180mm Short, Clear
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• 00840194410700: Orthex FootPlate 180mm, Blue
• 00840194410694: Orthex FootPlate 180mm, Green
• 00840194410687: Orthex FootPlate 180mm, Gold
• 00840194410670: Orthex FootPlate 180mm, Orange
• 00840194410663: Orthex FootPlate 180mm, Pink
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• 00840194410649: Orthex FootPlate 180mm, Clear