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

Mesh, Surgical, Acetabular, Hip, Prosthesis

21 CFR 878.3300 / General, Plastic Surgery
FDA source (opens on fda.gov)

JDJ is the FDA product code for Mesh, Surgical, Acetabular, Hip, Prosthesis, a class II device type, regulated under 21 CFR 878.3300. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JDJ
Device name
Mesh, Surgical, Acetabular, Hip, Prosthesis
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
7
Ingested recalls
0

Clearances, product code JDJ

By decision year
7 clearances under product code JDJ with a decision year between 1989 and 1997, 1997 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code JDJ by decision year
YearClearances
19891
19931
19962
19973

Applicants with the most clearances

Product code JDJ
Applicants holding the most 510(k) clearances under product code JDJ
ApplicantClearances
Osteonics Corp.2
Depuy, Inc.1
Howmedica Corp.1
Intermedics Orthopedics1
Link America, Inc.1
Smith & Nephew Richards, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 25 companies shown, in name order