OSTEOREMEDIES, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30105372873010537287OSTEOREMEDIES, LLC1Y2026-01-016800 Poplar Ave Ste 120 Memphis TN US 38138

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1636701675031434K253675OsteoRemedies Hip Spacer SystemKWL2025-12-23
1636701257334882K250760SPECTRUM GV Bone CementLOD2025-04-02
1636701617481376K242377REMEDY Stemmed Knee Spacer System with All-Poly Tibial ComponentJWH2024-10-02
1636701156256681K231556SPECTRUM® GV Bone CementLOD2023-12-20
1636701012985960K223650REMEDY Stemmed Knee SpacerJWH2023-01-05
1636701830394541K192995OsteoRemedies Hip Spacer SystemKWL2020-01-10
1636701051033727K191981REMEDY Acetabular CupKWL2019-08-23
1636701024110766K183017Remedy Femoral Component 84mm, Remedy Stemmed Knee SpacerJWH2019-07-25
1636701015932780K173967Remedy Acetabular CupKWL2018-02-22
1636701944002919K172906REMEDY PLUS Hip Spacer, UNITE PLUS Bone CementKWL2018-08-29
1636701688671667K152267Remedy® Shoulder SpacerKWS2015-12-15
1636701067678337K1124702GC HIP/KNEE MODULAR SPACERKWL2012-04-05
1636701784807856K092773CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FASTLOD2009-11-24
1636701030997451
1636701516518236
1636701945154247
1636701981295103

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KWL62025-12-23
LOD32025-04-02
JWH32024-10-02
KWS12015-12-15

PMN#

GUDID#

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