Remedy Spacer

GUDID 00855195006166

Remedy Tibial Insert Wedge 70mm

OSTEOREMEDIES, LLC

Orthopaedic cement spacer
Primary Device ID00855195006166
NIH Device Record Key8b0bc4cf-4558-470f-8f64-0fda00c5673e
Commercial Distribution StatusIn Commercial Distribution
Brand NameRemedy Spacer
Version Model NumberRKINMD
Company DUNS079596704
Company NameOSTEOREMEDIES, LLC
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100855195006166 [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 Number3
Public Version Date2018-07-06
Device Publish Date2016-01-20

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00855195006487Remedy Modular Humeral Stem Large
00855195006470Remedy Modular Humeral Stem Medium
00855195006463Remedy Modular Humeral Stem Small
00855195006456Remedy Modular Humeral Head 50mm
00855195006449Remedy Modular Humeral Head 45mm
00855195006432Remedy Modular Humeral Head 40mm
00855195006425Remedy Tibial Insert 80mm
00855195006418Remedy Tibial Insert 70mm
00855195006401Remedy Tibial Insert 60mm
00855195006395Remedy Femoral Component 74mm
00855195006388Remedy Femoral Component 64mm
00855195006371Remedy Femoral Component 54mm
00855195006364Remedy Tibial Component 80mm
00855195006357Remedy Tibial Component 70mm
00855195006340Remedy Tibial Component 60mm
00855195006333Remedy Modular Long Stem Large
00855195006326Remedy Modular Long Stem Medium
00855195006319Remedy Modular Long Stem Small
00855195006302Remedy Modular Stem Large
00855195006296Remedy Modular Stem Medium
00855195006289Remedy Modular Stem Small
00855195006272Remedy Modular Head 60mm
00855195006265Remedy Modular Head 54mm
00855195006258Remedy Modular Head 46mm
00855195006234Remedy Shoulder Humeral Stem Large
00855195006227Remedy Shoulder Humeral Stem Medium
00855195006210Remedy Shoulder Humeral Stem Small
00855195006203Remedy Shoulder Humeral Head 50mm
00855195006197Remedy Shoulder Humeral Head 45mm
00855195006180Remedy Shoulder Humeral Head 40mm
00855195006173Remedy Tibial Insert Wedge 80mm
00855195006166Remedy Tibial Insert Wedge 70mm
00855195006159Remedy Tibial Insert Wedge 60mm
00855195006142Remedy Femoral Component 74mm
00855195006135Remedy Femoral Component 64mm
00855195006128Remedy Femoral Component 54mm
00855195006111Remedy Tibial Component 80mm
00855195006104Remedy Tibial Component 70mm
00855195006098Remedy Tibial Component 60mm
00855195006081Remedy Modular Long Stem Large
00855195006074Remedy Modular Long Stem Medium
00855195006067Remedy Modular Long Stem Small
00855195006050Remedy Modular Stem Large
00855195006043Remedy Modular Stem Medium
00855195006036Remedy Modular Stem Small
00855195006029Remedy Modular Head 60mm
00855195006012Remedy Modular Head 54mm

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