Orthex External Fixation System ORTHEXSW

GUDID 00840194428002

Orthex P&C Software v2

ORTHOPEDIATRICS CORP.

External orthopaedic fixation frame calculation software

• Primary Device ID: 00840194428002
• NIH Device Record Key: 170b0b0e-c2d9-4959-a4ff-1ea5e3a94594
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orthex External Fixation System
• Version Model Number: ORTHEXSW
• Catalog Number: ORTHEXSW
• 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: false
• Lot Batch: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840194428002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223786

FDA Product Code

• OSN: Software for diagnosis/treatment

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-13
• Device Publish Date: 2023-03-03

On-Brand Devices [Orthex External Fixation System]

• 00840194411257: Half Pin Bolt, Small Bone - OFFSET
• 00840194411240: Half Pin Bolt, Small Bone - Slot
• 00840194411110: Orthex FootPlate 230mm Short, Purple
• 00840194411103: Orthex FootPlate 230mm Short, Blue
• 00840194411097: Orthex FootPlate 230mm Short, Green
• 00840194411080: Orthex FootPlate 230mm Short, Gold
• 00840194411073: Orthex FootPlate 230mm Short, Orange
• 00840194411066: Orthex FootPlate 230mm Short, Pink
• 00840194411059: Orthex FootPlate 230mm Short, Red
• 00840194411042: Orthex FootPlate 230mm Short, Clear
• 00840194411035: Orthex FootPlate 230mm, Purple
• 00840194411028: Orthex FootPlate 230mm, Blue
• 00840194411011: Orthex FootPlate 230mm, Green
• 00840194411004: Orthex FootPlate 230mm, Gold
• 00840194410991: Orthex FootPlate 230mm, Orange
• 00840194410984: Orthex FootPlate 230mm, Pink
• 00840194410977: Orthex FootPlate 230mm, Red
• 00840194410960: Orthex FootPlate 230mm, Clear
• 00840194410953: Orthex FootPlate 205mm Short, Purple
• 00840194410946: Orthex FootPlate 205mm Short, Blue
• 00840194410939: Orthex FootPlate 205mm Short, Green
• 00840194410922: Orthex FootPlate 205mm Short, Gold
• 00840194410915: Orthex FootPlate 205mm Short, Orange
• 00840194410908: Orthex FootPlate 205mm Short, Pink
• 00840194410892: Orthex FootPlate 205mm Short, Red
• 00840194410885: Orthex FootPlate 205mm Short, Clear
• 00840194410878: Orthex FootPlate 205mm, Purple
• 00840194410861: Orthex FootPlate 205mm, Blue
• 00840194410854: Orthex FootPlate 205mm, Green
• 00840194410847: Orthex FootPlate 205mm, Gold
• 00840194410830: Orthex FootPlate 205mm, Orange
• 00840194410823: Orthex FootPlate 205mm, Pink
• 00840194410816: Orthex FootPlate 205mm, Red
• 00840194410809: Orthex FootPlate 205mm, Clear
• 00840194410793: Orthex FootPlate 180mm Short, Purple
• 00840194410786: Orthex FootPlate 180mm Short, Blue
• 00840194410779: Orthex FootPlate 180mm Short, Green
• 00840194410762: Orthex FootPlate 180mm Short, Gold
• 00840194410755: Orthex FootPlate 180mm Short, Orange
• 00840194410748: Orthex FootPlate 180mm Short, Pink
• 00840194410731: Orthex FootPlate 180mm Short, Red
• 00840194410724: Orthex FootPlate 180mm Short, Clear
• 00840194410717: Orthex FootPlate 180mm, Purple
• 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
• 00840194410656: Orthex FootPlate 180mm, Red
• 00840194410649: Orthex FootPlate 180mm, Clear