Gemini SL 318-483/05

GUDID 04026575419999

Tibia Component - fixed bearing, PS, monoblock

WALDEMAR LINK GmbH & Co. KG

Uncoated knee tibia prosthesis, metallic
Primary Device ID04026575419999
NIH Device Record Key1e7e99cb-3be4-416d-b7b4-f38631a47e9f
Commercial Distribution StatusIn Commercial Distribution
Brand NameGemini SL
Version Model Number318-483/05
Catalog Number318-483/05
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 Batchfalse
Serial Numbertrue
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
GS104026575419999 [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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-12-11
Device Publish Date2019-04-17

On-Brand Devices [Gemini SL]

04026575419999Tibia Component - fixed bearing, PS, monoblock
04026575419982Tibia Component - fixed bearing, PS, monoblock
04026575419975Tibia Component - fixed bearing, PS, monoblock
04026575419968Tibia Component - fixed bearing, PS, monoblock
04026575419951Tibia Component - fixed bearing, PS, monoblock
04026575419944Tibia Component - fixed bearing, PS, monoblock
04026575419937Tibia Component - fixed bearing, PS, monoblock
04026575419920Tibia Component - fixed bearing, PS, monoblock
04026575419913Tibia Component - fixed bearing, PS, monoblock
04026575419906Tibia Component - fixed bearing, PS, monoblock
04026575419678Femoral Component - posterior stabilized
04026575419661Femoral Component - posterior stabilized
04026575419654Femoral Component - posterior stabilized
04026575419647Femoral Component - posterior stabilized
04026575419630Femoral Component - posterior stabilized
04026575419623Femoral Component - posterior stabilized
04026575419616Femoral Component - posterior stabilized
04026575419609Femoral Component - posterior stabilized
04026575419593Femoral Component - posterior stabilized
04026575419586Femoral Component - posterior stabilized
04026575419579Femoral Component - posterior stabilized
04026575419562Femoral Component - posterior stabilized
04026575419555Femoral Component - posterior stabilized
04026575419548Femoral Component - posterior stabilized
04026575419531Femoral Component - posterior stabilized
04026575419524Femoral Component - posterior stabilized
04026575419517Femoral Component
04026575419500Femoral Component
04026575419494Femoral Component
04026575419487Femoral Component
04026575419470Femoral Component
04026575419463Femoral Component
04026575419456Femoral Component
04026575419449Femoral Component
04026575419432Femoral Component
04026575419425Femoral Component
04026575419418Femoral Component
04026575419401Femoral Component
04026575419395Femoral Component
04026575419388Femoral Component
04026575419371Femoral Component
04026575419364Femoral Component
04026575417322Femoral Component - posterior stabilized
04026575417315Femoral Component - posterior stabilized
04026575417308Femoral Component
04026575417292Femoral Component
04026575412259Tibia Component - fixed bearing, posterior Stabili
04026575412242Tibia Component - fixed bearing, posterior Stabili
04026575412235Tibia Component - fixed bearing, posterior Stabili
04026575412228Tibia Component - fixed bearing, posterior Stabili

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