GMK Hinge Total Knee System

GUDID 07630030825460

Femoral Component Right, size 4

Medacta International SA

Uncoated knee femur prosthesis, metallic
Primary Device ID07630030825460
NIH Device Record Keyb2cf6134-7e42-4997-8210-1222a3dd6c9f
Commercial Distribution StatusIn Commercial Distribution
Brand NameGMK Hinge Total Knee System
Version Model Number02.09.2604R
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
GS107630030825460 [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 Date2019-12-11
Device Publish Date2014-11-18

On-Brand Devices [GMK Hinge Total Knee System]

07630030825767Tibial Augmentation # 6/10mm
07630030825750Tibial Augmentation # 6/5mm
07630030825743Tibial Augmentation # 5/10mm
07630030825736Tibial Augmentation # 5/5mm
07630030825729Tibial Augmentation # 4/10mm
07630030825712Tibial Augmentation # 4/5mm
07630030825705Tibial Augmentation # 3/10mm
07630030825699Tibial Augmentation # 3/5mm
07630030825682Tibial Augmentation # 2/10mm
07630030825675Tibial Augmentation # 2/5mm
07630030825668Tibial Augmentation # 1/10mm
07630030825651Tibial Augmentation # 1/5mm
07630030825644Tibial Augmentation # 0/10mm
07630030825637Tibial Augmentation # 0/5mm
07630030825620Fixed tibial tray Right, size 6
07630030825613Fixed tibial tray Left, size 6
07630030825606Fixed tibial tray Right, size 5
07630030825590Fixed tibial tray Left, size 5
07630030825583Fixed tibial tray Right, size 4
07630030825576Fixed tibial tray Left, size 4
07630030825569Fixed tibial tray Right, size 3
07630030825552Fixed tibial tray Left, size 3
07630030825545Fixed tibial tray Right, size 2
07630030825538Fixed tibial tray Left, size 2
07630030825521Fixed tibial tray Right, size 1
07630030825514Fixed tibial tray Left, size 1
07630030825507Femoral Component Right, size 6
07630030825491Femoral Component Left, size 6
07630030825484Femoral Component Right, size 5
07630030825477Femoral Component Left, size 5
07630030825460Femoral Component Right, size 4
07630030825453Femoral Component Left, size 4
07630030825446Femoral Component Right, size 3
07630030825439Femoral Component Left, size 3
07630030825422Femoral Component Right, size 2
07630030825415Femoral Component Left, size 2
07630030825408Femoral Component Right, size 1
07630030825392Femoral Component Left, size 1
07630030825385Fixed tibial insert # 6/26mm
07630030825378Fixed tibial insert # 6/23mm
07630030825361Fixed tibial insert # 6/20mm
07630030825354Fixed tibial insert # 6/17mm
07630030825347Fixed tibial insert # 6/14mm
07630030825330Fixed tibial insert # 6/12mm
07630030825316Fixed tibial insert # 5/26mm
07630030825309Fixed tibial insert # 5/23mm
07630030825293Fixed tibial insert # 5/20mm
07630030825286Fixed tibial insert # 5/17mm
07630030825279Fixed tibial insert # 5/14mm
07630030825262Fixed tibial insert # 5/12mm

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.