STATIX 301-320-140

GUDID 00841132141014

FootPlate, Statix 140mm Black

ORTHOPEDIATRICS CORP.

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

• Primary Device ID: 00841132141014
• NIH Device Record Key: c4f66d9b-54d6-4ba3-9003-6c9092b22c37
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STATIX
• Version Model Number: 301-320-140
• Catalog Number: 301-320-140
• 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: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841132141014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052196

FDA Product Code

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

Sterilization

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

[00841132141014]

Moist Heat or Steam Sterilization

[00841132141014]

Moist Heat or Steam Sterilization

[00841132141014]

Moist Heat or Steam Sterilization

[00841132141014]

Moist Heat or Steam Sterilization

[00841132141014]

Moist Heat or Steam Sterilization

[00841132141014]

Moist Heat or Steam Sterilization

[00841132141014]

Moist Heat or Steam Sterilization

[00841132141014]

Moist Heat or Steam Sterilization

[00841132141014]

Moist Heat or Steam Sterilization

[00841132141014]

Moist Heat or Steam Sterilization

[00841132141014]

Moist Heat or Steam Sterilization

[00841132141014]

Moist Heat or Steam Sterilization

[00841132141014]

Moist Heat or Steam Sterilization

[00841132141014]

Moist Heat or Steam Sterilization

[00841132141014]

Moist Heat or Steam Sterilization

[00841132141014]

Moist Heat or Steam Sterilization

[00841132141014]

Moist Heat or Steam Sterilization

[00841132141014]

Moist Heat or Steam Sterilization

[00841132141014]

Moist Heat or Steam Sterilization

[00841132141014]

Moist Heat or Steam Sterilization

[00841132141014]

Moist Heat or Steam Sterilization

[00841132141014]

Moist Heat or Steam Sterilization

[00841132141014]

Moist Heat or Steam Sterilization

[00841132141014]

Moist Heat or Steam Sterilization

[00841132141014]

Moist Heat or Steam Sterilization

[00841132141014]

Moist Heat or Steam Sterilization

[00841132141014]

Moist Heat or Steam Sterilization

[00841132141014]

Moist Heat or Steam Sterilization

[00841132141014]

Moist Heat or Steam Sterilization

[00841132141014]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-09
• Device Publish Date: 2020-02-28

On-Brand Devices [STATIX]

• 00841132141045: FootPlate, Statix 210mm Black
• 00841132141038: FootPlate, Statix 180mm Black
• 00841132141021: FootPlate, Statix 160mm Black
• 00841132141014: FootPlate, Statix 140mm Black
• 00841132141007: Ring, Statix Full 210mm Black
• 00841132140994: Ring, Statix Full 180mm Black
• 00841132140987: Ring, Statix Full 160mm Black
• 00841132140970: Ring, Statix Full 140mm Black
• 00841132140963: Ring, Statix 5/8 210mm Black
• 00841132140956: Ring, Statix 5/8 180mm Black
• 00841132140949: Ring, Statix 5/8 160mm Black
• 00841132140932: Ring, Statix 5/8 140mm Black
• 00841132140925: Ring, Statix Half 210mm Black
• 00841132140918: Ring, Statix Half 180mm Black
• 00841132140901: Ring, Statix Half 160mm Black
• 00841132140895: Ring, Statix Half 140mm Black
• 00841132140888: Ring, Statix 3/8 210mm Black
• 00841132140871: Ring, Statix 3/8 180mm Black
• 00841132140864: Ring, Statix 3/8 160mm Black
• 00841132140857: Ring, Statix 3/8 140mm Black