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

Implant, Fixation Device, Spinal

21 CFR 888.3060 / Orthopedic
FDA source (opens on fda.gov)

JDN is the FDA product code for Implant, Fixation Device, Spinal, a class II device type, regulated under 21 CFR 888.3060. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JDN
Device name
Implant, Fixation Device, Spinal
Regulation
21 CFR 888.3060
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
6
Ingested recalls
0

Clearances, product code JDN

By decision year
6 clearances under product code JDN with a decision year between 1976 and 1996, 1987 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code JDN by decision year
YearClearances
19761
19872
19902
19961

Applicants with the most clearances

Product code JDN
Applicants holding the most 510(k) clearances under product code JDN
ApplicantClearances
Biedermann Motech GmbH1
Depuy, Inc.1
Roseburg SA1
Sofamor Co.1
Stuart1
Synthes (USA) Products LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 15 companies shown, in name order