Remedy Spectrum GV Spacer

GUDID 00855195006586

REMEDY SPECTRUM GV Femoral Long Stem SM

OSTEOREMEDIES, LLC

Orthopaedic cement spacer
Primary Device ID00855195006586
NIH Device Record Keyedecf1fd-e0da-48fa-bdce-8e76b398910b
Commercial Distribution StatusIn Commercial Distribution
Brand NameRemedy Spectrum GV Spacer
Version Model NumberGVLSSM
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 Producttrue
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
GS100855195006586 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-12-21
Device Publish Date2018-11-20

On-Brand Devices [Remedy Spectrum GV Spacer]

00855195006609REMEDY SPECTRUM GV Femoral Long Stem LG
00855195006593REMEDY SPECTRUM GV Femoral Long Stem MD
00855195006586REMEDY SPECTRUM GV Femoral Long Stem SM
00855195006579REMEDY SPECTRUM GV Femoral Stem LG
00855195006562REMEDY SPECTRUM GV Femoral Stem MD
00855195006555REMEDY SPECTRUM GV Femoral Stem SM
00855195006548REMEDY SPECTRUM GV Femoral Head - 60mm
00855195006531REMEDY SPECTRUM GV Femoral Head - 54mm
00855195006524REMEDY SPECTRUM GV Femoral Head - 46mm
00850011453063REMEDY SPECTRUM® GV Femoral Head - 40mm

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