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

Prosthesis, Elbow, Constrained, Cemented

21 CFR 888.3150 / Orthopedic
FDA source (opens on fda.gov)

JDC is the FDA product code for Prosthesis, Elbow, Constrained, Cemented, a class II device type, regulated under 21 CFR 888.3150. As of , FDA records hold 29 510(k) clearances under this code, the most recent dated , and 20 recalls.

Classification record

Product code
JDC
Device name
Prosthesis, Elbow, Constrained, Cemented
Regulation
21 CFR 888.3150
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
29
Ingested recalls
21

Clearances, product code JDC

By decision year
29 clearances under product code JDC with a decision year between 1986 and 2019, 1998 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code JDC by decision year
YearClearances
19861
19871
19891
19902
19961
19984
19992
20003
20012
20031
20042
20052
20061
20091
20131
20151
20161
20192

Applicants with the most clearances

Product code JDC
Applicants holding the most 510(k) clearances under product code JDC
ApplicantClearances
Zimmer GmbH15
Biomet Manufacturing Corp2
Depuy Orthopaedics Inc.2
Depuy, Inc.2
Osteonics Corp.2
Allo Pro Corp.1
Arrow Intl., Inc.1
Biologically Oriented Prostheses1
Biomet Orthopedics, Inc.1
Lima Corporate S.p.A.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 55 companies shown, in name order