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

Mixer, Cement, For Clinical Use

21 CFR 888.4210 / Orthopedic
FDA source (opens on fda.gov)

JDZ is the FDA product code for Mixer, Cement, For Clinical Use, a class I device type, regulated under 21 CFR 888.4210. As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and 18 recalls.

Classification record

Product code
JDZ
Device name
Mixer, Cement, For Clinical Use
Regulation
21 CFR 888.4210
Device class
Class I
Review panel
Orthopedic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
13
Ingested recalls
18

Clearances, product code JDZ

By decision year
13 clearances under product code JDZ with a decision year between 1976 and 1994, 1976 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code JDZ by decision year
YearClearances
19762
19781
19791
19841
19852
19862
19891
19911
19942

Applicants with the most clearances

Product code JDZ
Applicants holding the most 510(k) clearances under product code JDZ
ApplicantClearances
Howmedica Corp.3
Stryker Corp.3
Zimmer GmbH2
Biodynamic Technologies, Inc.1
Dentsply Intl.1
Depuy, Inc.1
Diemolding Corp.1
Exactech, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 113 companies shown, in name order