510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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JDGClass II

Prosthesis, Hip, Femoral Component, Cemented, Metal

21 CFR 888.3360 / Orthopedic
FDA source (opens on fda.gov)

JDG is the FDA product code for Prosthesis, Hip, Femoral Component, Cemented, Metal, a class II device type, regulated under 21 CFR 888.3360. As of , FDA records hold 59 510(k) clearances under this code, the most recent dated , and 18 recalls.

Classification record

Product code
JDG
Device name
Prosthesis, Hip, Femoral Component, Cemented, Metal
Regulation
21 CFR 888.3360
Device class
Class II
Review panel
Orthopedic
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
59
Ingested recalls
18

Clearances, product code JDG

By decision year
59 clearances under product code JDG with a decision year between 1976 and 2022, 1976 the highest year at 10.
Show the numbers
510(k) clearances under FDA product code JDG by decision year
YearClearances
197610
19776
19784
19804
19812
19831
19851
19876
19882
19911
19935
19946
19954
19962
19991
20001
20181
20201
20221

Applicants with the most clearances

Product code JDG
Applicants holding the most 510(k) clearances under product code JDG
ApplicantClearances
Zimmer GmbH7
Howmedica Corp.7
Orthopedic Equipment Co., Inc.6
Cerenovus, Inc.4
Hexcel Medical4
Depuy, Inc.3
Dow Corning Wright3
Implantology Corp.3
Depuy, Inc.2
Mizuho Orthopedic Systems Inc2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 46 companies shown, in name order