RX-FIX

GUDID 00840420170613

WRIGHT MEDICAL TECHNOLOGY, INC.

External orthopaedic fixation system, single-use, non-sterile

• Primary Device ID: 00840420170613
• NIH Device Record Key: 054a9397-8fee-48d8-b690-6d6080540b95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RX-FIX
• Version Model Number: 03-5003
• Company DUNS: 807201207
• Company Name: WRIGHT MEDICAL TECHNOLOGY, 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: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840420170613 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051017

FDA Product Code

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

Sterilization

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

[00840420170613]

Moist Heat or Steam Sterilization

[00840420170613]

Moist Heat or Steam Sterilization

[00840420170613]

Moist Heat or Steam Sterilization

[00840420170613]

Moist Heat or Steam Sterilization

[00840420170613]

Moist Heat or Steam Sterilization

[00840420170613]

Moist Heat or Steam Sterilization

[00840420170613]

Moist Heat or Steam Sterilization

[00840420170613]

Moist Heat or Steam Sterilization

[00840420170613]

Moist Heat or Steam Sterilization

[00840420170613]

Moist Heat or Steam Sterilization

[00840420170613]

Moist Heat or Steam Sterilization

[00840420170613]

Moist Heat or Steam Sterilization

[00840420170613]

Moist Heat or Steam Sterilization

[00840420170613]

Moist Heat or Steam Sterilization

[00840420170613]

Moist Heat or Steam Sterilization

[00840420170613]

Moist Heat or Steam Sterilization

[00840420170613]

Moist Heat or Steam Sterilization

[00840420170613]

Moist Heat or Steam Sterilization

[00840420170613]

Moist Heat or Steam Sterilization

[00840420170613]

Moist Heat or Steam Sterilization

[00840420170613]

Moist Heat or Steam Sterilization

[00840420170613]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-15

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• 00889797109819 - N/A: 2024-10-15 SOLO™ Corner Removal Guide
• 00889797103923 - PROstep MIS: 2024-09-23 Chamfer Screw
• 00889797106351 - Made-To-Order: 2024-09-11 Swanson Toe Grommet Seater
• 00889797107433 - Made-To-Order: 2024-09-11 Inbone® Strike Rod
• 00889797107457 - Made-To-Order: 2024-09-11 Inbone® Strike Rod