MyKnee PPS

GUDID 07630030897238

MyKnee PPS MIS TibCutBlock-MRI-GMK-RL-#2

Medacta International SA

Orthopaedic prosthesis implantation instrument, single-use
Primary Device ID07630030897238
NIH Device Record Key1916555a-a9c7-4fbd-ab58-3c3a5c3fc344
Commercial Distribution StatusIn Commercial Distribution
Brand NameMyKnee PPS
Version Model Number8.2292
Company DUNS488227125
Company NameMedacta International SA
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107630030897238 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07630030897238]

Moist Heat or Steam Sterilization


[07630030897238]

Moist Heat or Steam Sterilization


[07630030897238]

Moist Heat or Steam Sterilization


[07630030897238]

Moist Heat or Steam Sterilization


[07630030897238]

Moist Heat or Steam Sterilization


[07630030897238]

Moist Heat or Steam Sterilization


[07630030897238]

Moist Heat or Steam Sterilization


[07630030897238]

Moist Heat or Steam Sterilization


[07630030897238]

Moist Heat or Steam Sterilization


[07630030897238]

Moist Heat or Steam Sterilization


[07630030897238]

Moist Heat or Steam Sterilization


[07630030897238]

Moist Heat or Steam Sterilization


[07630030897238]

Moist Heat or Steam Sterilization


[07630030897238]

Moist Heat or Steam Sterilization


[07630030897238]

Moist Heat or Steam Sterilization


[07630030897238]

Moist Heat or Steam Sterilization


[07630030897238]

Moist Heat or Steam Sterilization


[07630030897238]

Moist Heat or Steam Sterilization


[07630030897238]

Moist Heat or Steam Sterilization


[07630030897238]

Moist Heat or Steam Sterilization


[07630030897238]

Moist Heat or Steam Sterilization


[07630030897238]

Moist Heat or Steam Sterilization


[07630030897238]

Moist Heat or Steam Sterilization


[07630030897238]

Moist Heat or Steam Sterilization


[07630030897238]

Moist Heat or Steam Sterilization


[07630030897238]

Moist Heat or Steam Sterilization


[07630030897238]

Moist Heat or Steam Sterilization


[07630030897238]

Moist Heat or Steam Sterilization


[07630030897238]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-28
Device Publish Date2021-01-20

On-Brand Devices [MyKnee PPS]

07630030897788MyKnee PPS STD FemDisCutBlock-MRI-GMK-RM-#7
07630030897740MyKnee PPS STD FemDisCutBlock-MRI-GMK-RM-#6
07630030897702MyKnee PPS STD FemDisCutBlock-MRI-GMK-RM-#5
07630030897665MyKnee PPS STD FemDisCutBlock-MRI-GMK-RM-#4
07630030897627MyKnee PPS STD FemDisCutBlock-MRI-GMK-RM-#3
07630030897580MyKnee PPS STD FemDisCutBlock-MRI-GMK-RM-#2
07630030897542MyKnee PPS STD FemDisCutBlock-MRI-GMK-RM-#1
07630030897528MyKnee PPS STD FemDisCutBlock-MRI-GMK-LM-#7
07630030897481MyKnee PPS STD FemDisCutBlock-MRI-GMK-LM-#6
07630030897443MyKnee PPS STD FemDisCutBlock-MRI-GMK-LM-#5
07630030897405MyKnee PPS STD FemDisCutBlock-MRI-GMK-LM-#4
07630030897368MyKnee PPS STD FemDisCutBlock-MRI-GMK-LM-#3
07630030897320MyKnee PPS STD FemDisCutBlock-MRI-GMK-LM-#2
07630030897283MyKnee PPS STD FemDisCutBlock-MRI-GMK-LM-#1
07630030897276MyKnee PPS MIS TibCutBlock-MRI-GMK-RL-#6
07630030897269MyKnee PPS MIS TibCutBlock-MRI-GMK-RL-#5
07630030897252MyKnee PPS MIS TibCutBlock-MRI-GMK-RL-#4
07630030897245MyKnee PPS MIS TibCutBlock-MRI-GMK-RL-#3
07630030897238MyKnee PPS MIS TibCutBlock-MRI-GMK-RL-#2
07630030897221MyKnee PPS MIS TibCutBlock-MRI-GMK-RL-#1
07630030897207MyKnee PPS MIS TibCutBlock-MRI-GMK-LL-#6
07630030897184MyKnee PPS MIS TibCutBlock-MRI-GMK-LL-#5
07630030897160MyKnee PPS MIS TibCutBlock-MRI-GMK-LL-#4
07630030897146MyKnee PPS MIS TibCutBlock-MRI-GMK-LL-#3
07630030897122MyKnee PPS MIS TibCutBlock-MRI-GMK-LL-#2
07630030897108MyKnee PPS MIS TibCutBlock-MRI-GMK-LL-#1
07630030897085MyKnee PPS MIS TibCutBlock-MRI-GMK-RM-#6
07630030897061MyKnee PPS MIS TibCutBlock-MRI-GMK-RM-#5
07630030897047MyKnee PPS MIS TibCutBlock-MRI-GMK-RM-#4
07630030897023MyKnee PPS MIS TibCutBlock-MRI-GMK-RM-#3
07630030897009MyKnee PPS MIS TibCutBlock-MRI-GMK-RM-#2
07630030896989MyKnee PPS MIS TibCutBlock-MRI-GMK-RM-#1
07630030896965MyKnee PPS MIS TibCutBlock-MRI-GMK-LM-#6
07630030896941MyKnee PPS MIS TibCutBlock-MRI-GMK-LM-#5
07630030896927MyKnee PPS MIS TibCutBlock-MRI-GMK-LM-#4
07630030896903MyKnee PPS MIS TibCutBlock-MRI-GMK-LM-#3
07630030896880MyKnee PPS MIS TibCutBlock-MRI-GMK-LM-#2
07630030896866MyKnee PPS MIS TibCutBlock-MRI-GMK-LM-#1
07630030897757MyKnee PPS STD FemDisCutBlock-MRI-GMK-RM-#6+
07630030897719MyKnee PPS STD FemDisCutBlock-MRI-GMK-RM-#5+
07630030897672MyKnee PPS STD FemDisCutBlock-MRI-GMK-RM-#4+
07630030897634MyKnee PPS STD FemDisCutBlock-MRI-GMK-RM-#3+
07630030897597MyKnee PPS STD FemDisCutBlock-MRI-GMK-RM-#2+
07630030897559MyKnee PPS STD FemDisCutBlock-MRI-GMK-RM-#1+
07630030897498MyKnee PPS STD FemDisCutBlock-MRI-GMK-LM-#6+
07630030897450MyKnee PPS STD FemDisCutBlock-MRI-GMK-LM-#5+
07630030897412MyKnee PPS STD FemDisCutBlock-MRI-GMK-LM-#4+
07630030897375MyKnee PPS STD FemDisCutBlock-MRI-GMK-LM-#3+
07630030897337MyKnee PPS STD FemDisCutBlock-MRI-GMK-LM-#2+
07630030897290MyKnee PPS STD FemDisCutBlock-MRI-GMK-LM-#1+

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