GMK 3D Metal Tibial Tray

GUDID 07630345710857

3DMetal Tibial Tray Size 5L

Medacta International SA

Trabeculated bicondylar knee tibia prosthesis
Primary Device ID07630345710857
NIH Device Record Key9c97a537-8660-46e0-a80a-9283ad0befe9
Commercial Distribution StatusIn Commercial Distribution
Brand NameGMK 3D Metal Tibial Tray
Version Model Number02.12.3D05L
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
GS107630345710857 [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 Date2022-09-02
Device Publish Date2022-08-25

On-Brand Devices [GMK 3D Metal Tibial Tray]

076303457109253DMetal Tibial Tray Size T4I3R
076303457109183DMetal Tibial Tray Size T4I3L
076303457109013DMetal Tibial Tray Size T3I4R
076303457108953DMetal Tibial Tray Size T3I4L
076303457108883DMetal Tibial Tray Size 6R
076303457108713DMetal Tibial Tray Size 6L
076303457108643DMetal Tibial Tray Size 5R
076303457108573DMetal Tibial Tray Size 5L
076303457108403DMetal Tibial Tray Size 4R
076303457108333DMetal Tibial Tray Size 4L
076303457108263DMetal Tibial Tray Size 3R
076303457108193DMetal Tibial Tray Size 3L
076303457108023DMetal Tibial Tray Size 2R
076303457107963DMetal Tibial Tray Size 2L
076303457107893DMetal Tibial Tray Size 1R
076303457107723DMetal Tibial Tray Size 1L
076303457177403DMetal Tibial Tray Size 1+L
076303457175663DMetal Tibial Tray Size 4+R
076303457175593DMetal Tibial Tray Size 4+L
076303457175423DMetal Tibial Tray Size 3+R
076303457175353DMetal Tibial Tray Size 3+L
076303457175283DMetal Tibial Tray Size 2+R
076303457175113DMetal Tibial Tray Size 2+L
076303457175043DMetal Tibial Tray Size 1+R
076303457109493DMetal Tibial Tray Size 5+R
076303457109323DMetal Tibial Tray Size 5+L

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