Orthex External Fixation System 351M-M6-03

GUDID 00840194466141

Pin Cube, Stainless Male

ORTHOPEDIATRICS CORP.

External orthopaedic fixation system, single-use
Primary Device ID00840194466141
NIH Device Record Keyc17e4111-49a0-4d56-a9a0-96e199896213
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrthex External Fixation System
Version Model Number351M-M6-03
Catalog Number351M-M6-03
Company DUNS796416191
Company NameORTHOPEDIATRICS CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840194466141 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


[00840194466141]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-06
Device Publish Date2024-02-27

On-Brand Devices [Orthex External Fixation System]

00840194411257Half Pin Bolt, Small Bone - OFFSET
00840194411240Half Pin Bolt, Small Bone - Slot
00840194411110Orthex FootPlate 230mm Short, Purple
00840194411103Orthex FootPlate 230mm Short, Blue
00840194411097Orthex FootPlate 230mm Short, Green
00840194411080Orthex FootPlate 230mm Short, Gold
00840194411073Orthex FootPlate 230mm Short, Orange
00840194411066Orthex FootPlate 230mm Short, Pink
00840194411059Orthex FootPlate 230mm Short, Red
00840194411042Orthex FootPlate 230mm Short, Clear
00840194411035Orthex FootPlate 230mm, Purple
00840194411028Orthex FootPlate 230mm, Blue
00840194411011Orthex FootPlate 230mm, Green
00840194411004Orthex FootPlate 230mm, Gold
00840194410991Orthex FootPlate 230mm, Orange
00840194410984Orthex FootPlate 230mm, Pink
00840194410977Orthex FootPlate 230mm, Red
00840194410960Orthex FootPlate 230mm, Clear
00840194410953Orthex FootPlate 205mm Short, Purple
00840194410946Orthex FootPlate 205mm Short, Blue
00840194410939Orthex FootPlate 205mm Short, Green
00840194410922Orthex FootPlate 205mm Short, Gold
00840194410915Orthex FootPlate 205mm Short, Orange
00840194410908Orthex FootPlate 205mm Short, Pink
00840194410892Orthex FootPlate 205mm Short, Red
00840194410885Orthex FootPlate 205mm Short, Clear
00840194410878Orthex FootPlate 205mm, Purple
00840194410861Orthex FootPlate 205mm, Blue
00840194410854Orthex FootPlate 205mm, Green
00840194410847Orthex FootPlate 205mm, Gold
00840194410830Orthex FootPlate 205mm, Orange
00840194410823Orthex FootPlate 205mm, Pink
00840194410816Orthex FootPlate 205mm, Red
00840194410809Orthex FootPlate 205mm, Clear
00840194410793Orthex FootPlate 180mm Short, Purple
00840194410786Orthex FootPlate 180mm Short, Blue
00840194410779Orthex FootPlate 180mm Short, Green
00840194410762Orthex FootPlate 180mm Short, Gold
00840194410755Orthex FootPlate 180mm Short, Orange
00840194410748Orthex FootPlate 180mm Short, Pink
00840194410731Orthex FootPlate 180mm Short, Red
00840194410724Orthex FootPlate 180mm Short, Clear
00840194410717Orthex FootPlate 180mm, Purple
00840194410700Orthex FootPlate 180mm, Blue
00840194410694Orthex FootPlate 180mm, Green
00840194410687Orthex FootPlate 180mm, Gold
00840194410670Orthex FootPlate 180mm, Orange
00840194410663Orthex FootPlate 180mm, Pink
00840194410656Orthex FootPlate 180mm, Red
00840194410649Orthex FootPlate 180mm, Clear

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