Megasystem C 99-0146/28

GUDID 04026575992942

Prosthesis Stem - straight,modular, total femur replacement

WALDEMAR LINK GmbH & Co. KG

Knee femur stem prosthesis
Primary Device ID04026575992942
NIH Device Record Key53302d0a-eaca-4eca-81c7-f2d0fd079bda
Commercial Distribution StatusIn Commercial Distribution
Brand NameMegasystem C
Version Model Number99-0146/28
Catalog Number99-0146/28
Company DUNS315675488
Company NameWALDEMAR LINK GmbH & Co. KG
Device Count1
DM Exempttrue
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
GS104026575992942 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-04-20
Device Publish Date2015-11-01

On-Brand Devices [Megasystem C]

04026575992973Prosthesis Stem - straight,modular, total femur replacement
04026575992942Prosthesis Stem - straight,modular, total femur replacement
04026575992935Prosthesis Stem - anatomical,modular, total femur replacement
04026575992928Prosthesis Stem - anatomical,modular, total femur replacement
04026575992911Prosthesis Stem - anatomical,modular, total femur replacement
04026575992904Prosthesis Stem - anatomical,modular, total femur replacement
04026575400133Prosthesis Stem - anatomical,modular, total femur replacement
04026575400126Prosthesis Stem - straight,modular, total femur replacement
04026575400119Prosthesis Stem - straight,modular, total femur replacement

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