SixFix Circular Fixation System 76-10203

GUDID 00855967006660

Rancho Cube, 4-Hole

ARROWHEAD DE LLC

External orthopaedic fixation system, single-use, non-sterile
Primary Device ID00855967006660
NIH Device Record Key0db34c21-67d8-45be-9d2e-2bf95d5b33d8
Commercial Distribution StatusIn Commercial Distribution
Brand NameSixFix Circular Fixation System
Version Model Number1
Catalog Number76-10203
Company DUNS054367577
Company NameARROWHEAD DE LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100855967006660 [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

[00855967006660]

Moist Heat or Steam Sterilization


[00855967006660]

Moist Heat or Steam Sterilization


[00855967006660]

Moist Heat or Steam Sterilization


[00855967006660]

Moist Heat or Steam Sterilization


[00855967006660]

Moist Heat or Steam Sterilization


[00855967006660]

Moist Heat or Steam Sterilization


[00855967006660]

Moist Heat or Steam Sterilization


[00855967006660]

Moist Heat or Steam Sterilization


[00855967006660]

Moist Heat or Steam Sterilization


[00855967006660]

Moist Heat or Steam Sterilization


[00855967006660]

Moist Heat or Steam Sterilization


[00855967006660]

Moist Heat or Steam Sterilization


[00855967006660]

Moist Heat or Steam Sterilization


[00855967006660]

Moist Heat or Steam Sterilization


[00855967006660]

Moist Heat or Steam Sterilization


[00855967006660]

Moist Heat or Steam Sterilization


[00855967006660]

Moist Heat or Steam Sterilization


[00855967006660]

Moist Heat or Steam Sterilization


[00855967006660]

Moist Heat or Steam Sterilization


[00855967006660]

Moist Heat or Steam Sterilization


[00855967006660]

Moist Heat or Steam Sterilization


[00855967006660]

Moist Heat or Steam Sterilization


[00855967006660]

Moist Heat or Steam Sterilization


[00855967006660]

Moist Heat or Steam Sterilization


[00855967006660]

Moist Heat or Steam Sterilization


[00855967006660]

Moist Heat or Steam Sterilization


[00855967006660]

Moist Heat or Steam Sterilization


[00855967006660]

Moist Heat or Steam Sterilization


[00855967006660]

Moist Heat or Steam Sterilization


[00855967006660]

Moist Heat or Steam Sterilization


[00855967006660]

Moist Heat or Steam Sterilization


[00855967006660]

Moist Heat or Steam Sterilization


[00855967006660]

Moist Heat or Steam Sterilization


[00855967006660]

Moist Heat or Steam Sterilization


[00855967006660]

Moist Heat or Steam Sterilization


[00855967006660]

Moist Heat or Steam Sterilization


[00855967006660]

Moist Heat or Steam Sterilization


[00855967006660]

Moist Heat or Steam Sterilization


[00855967006660]

Moist Heat or Steam Sterilization


[00855967006660]

Moist Heat or Steam Sterilization


[00855967006660]

Moist Heat or Steam Sterilization


[00855967006660]

Moist Heat or Steam Sterilization


[00855967006660]

Moist Heat or Steam Sterilization


[00855967006660]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-04
Device Publish Date2020-08-27

On-Brand Devices [SixFix Circular Fixation System]

008559670067762/3 Ring, 195mm
008559670067692/3 Ring, 175mm
008559670067522/3 Ring, 155mm
008559670067452/3 Ring, 135mm
00855967006738Static Strut, Extra Long (80mm)
00855967006721Static Strut, Long (60mm)
00855967006714Static Strut, Medium (40mm)
00855967006707Static Strut, Short (30mm)
00855967006691Rancho w/Post, 3-Hole
00855967006684Rancho w/Post, 2-Hole
00855967006677Rancho Cube, 5-Hole
00855967006660Rancho Cube, 4-Hole
008559670066534-Hole Threaded Posts
008559670066462-Hole Threaded Posts
00855967006639Half Pin Fixation Bolt
00855967006622Wire Fixation Bolt
00855967006615Foot Arch, 180mm
00855967006608Foot Arch, 150mm
00855967006592Foot Rocker, Short
00855967006585Foot Rocker, Long
00855967006578Foot Ring, 180mm, Short
00855967006561Foot Ring, 180mm, Long
00855967006554Foot Ring, 150mm, Short
00855967006547Foot Ring, 150mm, Long
00855967006530Full Ring, 195mm
00855967006523Full Ring, 175mm
00855967006516Full Ring, 155mm
00855967006509Full Ring, 135mm
00855967006493Strut Clip, Aluminum
00855967006486Strut Assembly, Base Unit

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