JEYClass II

Plate, Bone

21 CFR 872.4760 / Dental

JEY is the FDA product code for Plate, Bone, a class II device type, regulated under 21 CFR 872.4760. As of 2026-09-10, FDA records hold 294 510(k) clearances under this code, the most recent dated 2026-08-17, and 111 recalls.

Classification record

Product code: JEY
Device name: Plate, Bone
Regulation: 21 CFR 872.4760
Device class: Class II
Review panel: Dental
Submission type: 510(k)
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 294
Ingested recalls: 111

Clearances, product code JEY

By decision year

294 clearances under product code JEY with a decision year between 1984 and 2026, 2001 the highest year at 23.

Show the numbers

510(k) clearances under FDA product code JEY by decision year
Year	Clearances
1984	1
1986	9
1987	1
1988	2
1990	5
1991	1
1992	4
1993	3
1994	9
1995	16
1996	9
1997	11
1998	12
1999	11
2000	12
2001	23
2002	23
2003	13
2004	8
2005	10
2006	3
2007	9
2008	7
2009	4
2010	6
2011	5
2012	10
2013	8
2014	6
2015	7
2016	1
2017	5
2018	7
2019	6
2020	6
2021	4
2022	5
2023	2
2024	5
2025	2
2026	3

Applicants with the most clearances

Product code JEY

Applicants holding the most 510(k) clearances under product code JEY
Applicant	Clearances
Synthes (USA) Products LLC	41
Biomet Microfixation	23
KLS-Martin L.P.	18
Stryker Corp.	18
Bioplate Inc	16
Inion Oy	8
Bionx Implants, Inc.	7
Medicon, E.G.	7
Osteomed	7
Biomedics	6

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 96 companies shown, in name order