510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
JDXClass II

Instrument, Surgical, Sonic And Accessory/Attachment

21 CFR 888.4580 / Orthopedic
FDA source (opens on fda.gov)

JDX is the FDA product code for Instrument, Surgical, Sonic And Accessory/Attachment, a class II device type, regulated under 21 CFR 888.4580. As of , FDA records hold 23 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
JDX
Device name
Instrument, Surgical, Sonic And Accessory/Attachment
Regulation
21 CFR 888.4580
Device class
Class II
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
23
Ingested recalls
2

Clearances, product code JDX

By decision year
23 clearances under product code JDX with a decision year between 1980 and 2021, 1991 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code JDX by decision year
YearClearances
19801
19861
19891
19901
19913
19931
19961
20001
20021
20031
20051
20071
20092
20102
20131
20161
20171
20181
20211

Applicants with the most clearances

Product code JDX
Applicants holding the most 510(k) clearances under product code JDX
ApplicantClearances
Orthosonics, Ltd.3
Advanced Osseous Technologies2
Buckman Co., Inc.2
Mectron S.p.A.2
Amedica Corp.1
Zimmer GmbH1
Brassler USA1
C.L. Mcintosh & Assoc., Inc.1
Depuy, Inc.1
E.M.S. - Electro Medical Systems SA1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 34 companies shown, in name order