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HSD — Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Class II

FDA Device Classification

Classification Details

Product Code
HSD
Device Class
Class II
Regulation Number
888.3690
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K233260arthrexUnivers Revers CA Head and AdapterFebruary 12, 2024
K221232arthrexUnivers Revers Humeral Cup ImplantMay 19, 2022
K191433implantcastAGILON® XO Shoulder Replacement SystemNovember 12, 2020
K193122biocore9Biocore9 Humeral Resurfacing SystemMay 15, 2020
K173964arthrosurfaceOVOMotion Shoulder Arthroplasty SystemApril 18, 2018
K161782arthrexArthrex Univers Revers Shoulder Prosthesis SystemNovember 21, 2016
K161620zimmerAnatomical Shoulder Domelock Dome centricNovember 1, 2016
K151527arthrexArthrex Univers Revers CA Heads and AdaptersApril 19, 2016
K142942arthrosurfaceHemiCAP Humeral Head XL (HHXL) Articular Resurfacing SystemDecember 19, 2014
K131298exactechEXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEMNovember 26, 2013
K130759fx solutionsHUMELOCK II CEMENTLESS SHOULDER SYSTEMNovember 9, 2013
K130675arthrexARTHREX UNIVERS II CA HEADSOctober 30, 2013
K130635ingen orthopedicsSEVIIN SURFACE REPLACEMENT SHOULDERAugust 26, 2013
K121714smith and nephewSMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTSSeptember 7, 2012
K112900lima corporateSMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADSJune 1, 2012
K112983tecresSPACER-SDecember 12, 2011
K111097fx solutionsHUMELOCK CEMENTED SHOULDER PROSTHESISNovember 9, 2011
K082715depuy orthopaedicsDEPUY GLOBAL AP CTA HUMERAL HEADDecember 18, 2008
K080990depuy orthopaedicsDEPUY GLOBAL C.AP. CTA RESURFACING SHOULDERAugust 8, 2008
K073331dvo extremity solutionsDVO EXTENDED ARTICULATION HUMERAL HEADSFebruary 19, 2008