Unicondylar Sled Prosthesis 15-2028/13

GUDID 04026575359455

Tibia Plateau,all-polyethylene

WALDEMAR LINK GmbH & Co. KG

Uncoated unicondylar knee tibia prosthesis, polyethylene
Primary Device ID04026575359455
NIH Device Record Keyc19919a5-3444-4b4b-b73d-9ae9650b174a
Commercial Distribution StatusIn Commercial Distribution
Brand NameUnicondylar Sled Prosthesis
Version Model Number15-2028/13
Catalog Number15-2028/13
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
GS104026575359455 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2023-03-13
Device Publish Date2015-11-01

On-Brand Devices [Unicondylar Sled Prosthesis]

04026575436750Tibial Component Metal-Backed PE-PorEx
04026575436743Tibial Component Metal-Backed PE-PorEx
04026575436736Tibial Component Metal-Backed PE-PorEx
04026575429226Tibial Component Metal-Backed PE-PorEx
04026575429219Tibial Component Metal-Backed PE-PorEx
04026575429202Tibial Component Metal-Backed PE-PorEx
04026575429189Tibial Component Metal-Backed PE-PorEx
04026575429172Tibial Component Metal-Backed PE-PorEx
04026575429165Tibial Component Metal-Backed PE-PorEx
04026575429141Tibial Component Metal-Backed PE-PorEx
04026575429134Tibial Component Metal-Backed PE-PorEx
04026575429127Tibial Component Metal-Backed PE-PorEx
04026575429103Femoral Component
04026575429097Femoral Component
04026575429080Femoral Component
04026575429073Femoral Component
04026575436729Tibia Plateau,metal-backed
04026575436712Tibia Plateau,metal-backed
04026575436705Tibia Plateau,metal-backed
04026575359486Tibia Plateau,all-polyethylene
04026575359479Tibia Plateau,all-polyethylene
04026575359462Tibia Plateau,all-polyethylene
04026575359455Tibia Plateau,all-polyethylene
04026575209491Femoral Component
04026575044160Tibia Plateau,metal-backed
04026575044153Tibia Plateau,metal-backed
04026575044146Tibia Plateau,metal-backed
04026575044122Tibia Plateau,metal-backed
04026575044115Tibia Plateau,metal-backed
04026575044108Tibia Plateau,metal-backed
04026575044085Tibia Plateau,metal-backed
04026575044078Tibia Plateau,metal-backed
04026575044061Tibia Plateau,metal-backed
04026575044047Tibia Plateau,all-polyethylene
04026575044030Tibia Plateau,all-polyethylene
04026575044023Tibia Plateau,all-polyethylene
04026575044016Tibia Plateau,all-polyethylene
04026575044009Tibia Plateau,all-polyethylene
04026575043996Tibia Plateau,all-polyethylene
04026575043989Tibia Plateau,all-polyethylene
04026575043972Tibia Plateau,all-polyethylene
04026575043965Tibia Plateau,all-polyethylene
04026575043958Tibia Plateau,all-polyethylene
04026575043941Tibia Plateau,all-polyethylene
04026575043934Tibia Plateau,all-polyethylene
04026575043910Femoral Component
04026575043903Femoral Component
04026575043897Femoral Component

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