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

Prosthesis, Hip, Cement Restrictor

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

JDK is the FDA product code for Prosthesis, Hip, Cement Restrictor, a class II device type, regulated under 21 CFR 878.3300. As of , FDA records hold 54 510(k) clearances under this code, the most recent dated , and 12 recalls.

Classification record

Product code
JDK
Device name
Prosthesis, Hip, Cement Restrictor
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
54
Ingested recalls
12

Clearances, product code JDK

By decision year
54 clearances under product code JDK with a decision year between 1983 and 2021, 2001 the highest year at 9.
Show the numbers
510(k) clearances under FDA product code JDK by decision year
YearClearances
19832
19841
19871
19892
19902
19912
19921
19941
19971
19991
20019
20028
20039
20043
20056
20064
20211

Applicants with the most clearances

Product code JDK
Applicants holding the most 510(k) clearances under product code JDK
ApplicantClearances
Osteonics Corp.6
Medtronic Sofamor Danek5
Spinal Concepts, Inc.5
Interpore Cross Intl.2
Life Spine2
Medtronic Sofamor Danek USA Inc2
Spine Next SA2
Theken Surgical,Llc2
Amedica Corp.1
American Ortomed Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 22 companies shown, in name order