KneeAlign 2 401744

GUDID 00810832030522

Special- Single Pin Tibial Jig, Right

ORTHALIGN, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID00810832030522
NIH Device Record Keyb91f954f-6b4b-44fa-b07f-76a257036ef4
Commercial Distribution StatusIn Commercial Distribution
Brand NameKneeAlign 2
Version Model Number401744
Catalog Number401744
Company DUNS023266163
Company NameORTHALIGN, INC.
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 Usefalse
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

Customer Support Contacts

Phone866-582-0879
Email[email protected]

Device Identifiers

Device Issuing AgencyDevice ID
GS100810832030522 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810832030522]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-10
Device Publish Date2020-01-31

On-Brand Devices [KneeAlign 2]

00810832030393KneeAlign 2 Instrument Tray Base
00810832030386KneeAlign 2 Instrument Tray Base
00810832030263Tibial Cutting Block, Left, Rapid Traverse
00810832030256Tibial Cutting Block, Right, Rapid Traverse
00810832030232Balancing Application Instrument Kit
00810832030225BRACKET NAV UNIT, KTIS
00810832030218GUIDE,ALIGNMENT,KTIS
00810832030201Tibial Tensor Instrument
00810832030195Femoral Tensor Instrument
00810832030058BASE, TRAY, 10x10, KTIS
00858704006800KneeAlign 2 Instrument Kit
00858704006510Button Cap, Black
00858704006503Button Cap, White
00858704006480Femoral Drill Guide, Neutral
00858704006459Threaded Pin, Headless, 65mm
00858704006442Threaded Pin, Headed, 46mm
00858704006435Pin Driver, Tri-Flat, 3.2mm
00858704006428Pin Driver
00858704006411KneeAlign 2 Instrument Tray Base
00858704006404KneeAlign 2 Inner Tray
00858704006398Instrument Tray Lid
00858704006381KneeAlign 2 Instrument Tray Base
008587040063742.5mm Ball Driver
00858704006367KneeAlign 2 Mounting Bracket
00858704006343Distal Guide Assembly
00858704006336MicroBlock Assembly
00858704006329Universal Tibial Cutting Block
00858704006312Reversed Tibial Cutting Block, Right
00858704006305Reversed Tibial Cutting Block, Left
00858704006299KneeAlign 2 Tibial Jig Body
00858704006282KneeAlign 2 Tibial Jig Body, Streamlined
00858704006275KneeAlign 2 Tibial Jig Body
00858704006268Calf Strap
00858704006251Extended Tibial Cutting Block, Right
00858704006244Extended Tibial Cutting Block, Left
00858704006237Adjustable Resection Stylus
00858704006220Shin Spacer
00858704006213Resection Stylus (4-8mm)
00858704006206Resection Stylus (4-8mm)
00858704006190Tibial Cutting Block, Right
00858704006183Tibial Cutting Block, Right
00858704006176Malleolar Probe, Curved
00858704006169Malleolar Probe, Curved
00858704006152Malleolar Probe
00858704006145Malleolar Probe
00858704006138Ankle Tube
00858704006121Ankle Tube
00858704006114Midline Probe
00858704006107Midline Probe
00858704006091Tibial Cutting Block, Left

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