3DMetal Diaphyseal Femoral Cones

GUDID 07630971259249

3DMetal Diaphyseal Femoral Cone Size Extra Large

Medacta International SA

Knee arthroplasty wedge
Primary Device ID07630971259249
NIH Device Record Key1b7d04a2-eec4-47e3-82a4-95725382166f
Commercial Distribution StatusIn Commercial Distribution
Brand Name3DMetal Diaphyseal Femoral Cones
Version Model Number02.07.FCXL30
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
GS107630971259249 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-24
Device Publish Date2020-03-16

On-Brand Devices [3DMetal Diaphyseal Femoral Cones]

076309712592493DMetal Diaphyseal Femoral Cone Size Extra Large
076309712592323DMetal Diaphyseal Femoral Cone Size Small
076309712592253DMetal Diaphyseal Femoral Cone Size Medium
076309712592183DMetal Diaphyseal Femoral Cone Size Large

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