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JDG — Prosthesis, Hip, Femoral Component, Cemented, Metal Class II

FDA Device Classification

FDA product code JDG covers "Prosthesis, Hip, Femoral Component, Cemented, Metal", a Class II medical device regulated under 21 CFR 888.3360. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
JDG
Device Class
Class II
Regulation Number
888.3360
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K212431biometBiomet Answer/Impact/Integral Distal Centralizer/Centering SleeveFebruary 7, 2022
K193546biometDistal CentralizersSeptember 25, 2020
K173499stryker orthopaedicsExeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsMarch 19, 2018
K001984stelkastPROGENY FORGED COCR CEMENTED FEMORAL COMPONENTSeptember 27, 2000
K992234corin usaTHE TAPER-FIT TOTAL HIP SYSTEMNovember 10, 1999
K962002exactechAURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEMAugust 8, 1996
K955171nexmedNEXLOCK FEMORAL STEMFebruary 9, 1996
K953653turnkey intergration usaLUBINUS SP II HIP SYSTEMNovember 6, 1995
K953067howmedicaHIP FRACTURE STEM FENESTRATION PLUGAugust 21, 1995
K945783orthometORTHOMET TITANIUM HYBRID FEMORAL STEMMay 30, 1995
K951083stelkastPROFORM CEMENTED FEMORAL COMPONENTMay 22, 1995
K942479biometINTEGRAL CO-CR FEMORAL COMPONENTSeptember 20, 1994
K942027biometIMPACT CO-CR 1-PIECE FEMORAL COMPONENTSeptember 19, 1994
K942028biometRX90 FEMORAL COMPONENTSeptember 19, 1994
K931194biometCO-CR ANSWER FEMORAL COMPONENTMay 5, 1994
K935078joint medical productsS-ROM TOTAL HIP REPLACEMENT SYSTEMMarch 9, 1994
K933871wrightmedicaltechnologyincBRIDGE(TM) HIP SYSTEMFebruary 23, 1994
K915385implantologyPPC HIP STEM COMPONENTMay 17, 1993
K924099implantologyUFC HIP STEM COMPONENTApril 30, 1993
K915391implantologyFPC HIP STEM COMPONENTApril 30, 1993

FDA data resources