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

Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)

21 CFR 888.3320 / Orthopedic
FDA source (opens on fda.gov)

JDL is the FDA product code for Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component), a class III device type, regulated under 21 CFR 888.3320. As of , FDA records hold 45 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
JDL
Device name
Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
Regulation
21 CFR 888.3320
Device class
Class III
Review panel
Orthopedic
Submission type
PMA
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
45
Ingested recalls
5

Clearances, product code JDL

By decision year
45 clearances under product code JDL with a decision year between 1977 and 2008, 1993 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code JDL by decision year
YearClearances
19771
19791
19821
19831
19842
19854
19864
19872
19893
19901
19923
19936
19946
19951
20011
20043
20052
20061
20071
20081

Applicants with the most clearances

Product code JDL
Applicants holding the most 510(k) clearances under product code JDL
ApplicantClearances
Wrightmedicaltechnologyinc7
Howmedica Corp.5
Zimmer GmbH3
Kirschner Medical Corp.3
Osteonics Corp.3
Advanced Biosearch Assn.2
Dow Corning Wright2
Implantology Corp.2
Intermedics Orthopedics2
Link America, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 39 companies shown, in name order