MiniMAX Stems

GUDID 07630030803147

Cementless anatomical stem right size 0

Medacta International SA

Press-fit hip femur prosthesis, one-piece
Primary Device ID07630030803147
NIH Device Record Key64ef0c37-5ea5-4eef-9740-9b4bda9aed4e
Commercial Distribution StatusIn Commercial Distribution
Brand NameMiniMAX Stems
Version Model Number01.13.100R
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
GS107630030803147 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-08-22

On-Brand Devices [MiniMAX Stems]

07630030803307Cementless anatomical stem right size 8
07630030803291Cementless anatomical stem left size 8
07630030803284Cementless anatomical stem right size 7
07630030803277Cementless anatomical stem left size 7
07630030803260Cementless anatomical stem right size 6
07630030803253Cementless anatomical stem left size 6
07630030803246Cementless anatomical stem right size 5
07630030803239Cementless anatomical stem left size 5
07630030803222Cementless anatomical stem right size 4
07630030803215Cementless anatomical stem left size 4
07630030803208Cementless anatomical stem right size 3
07630030803192Cementless anatomical stem left size 3
07630030803185Cementless anatomical stem right size 2
07630030803178Cementless anatomical stem left size 2
07630030803161Cementless anatomical stem right size 1
07630030803154Cementless anatomical stem left size 1
07630030803147Cementless anatomical stem right size 0
07630030803130Cementless anatomical stem left size 0
07630971238800Cementless Anatomical Stem, Right, Size 9
07630971238794Cementless Anatomical Stem, Left, Size 9

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