GXNClass II

Plate, Cranioplasty, Preformed, Non-Alterable

21 CFR 882.5330 / Neurology

GXN is the FDA product code for Plate, Cranioplasty, Preformed, Non-Alterable, a class II device type, regulated under 21 CFR 882.5330. As of 2026-09-10, FDA records hold 57 510(k) clearances under this code, the most recent dated 2026-06-25, and 11 recalls.

Classification record

Product code: GXN
Device name: Plate, Cranioplasty, Preformed, Non-Alterable
Regulation: 21 CFR 882.5330
Device class: Class II
Review panel: Neurology
Submission type: 510(k)
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 57
Ingested recalls: 11

Clearances, product code GXN

By decision year

57 clearances under product code GXN with a decision year between 1998 and 2026, 2020 the highest year at 5.

Show the numbers

510(k) clearances under FDA product code GXN by decision year
Year	Clearances
1998	3
1999	3
2000	1
2001	2
2002	1
2003	3
2004	2
2005	2
2006	3
2007	2
2008	1
2011	2
2012	3
2013	1
2014	2
2015	2
2016	1
2017	2
2018	3
2020	5
2021	3
2022	2
2023	1
2024	1
2025	2
2026	4

Applicants with the most clearances

Product code GXN

Applicants holding the most 510(k) clearances under product code GXN
Applicant	Clearances
Longeviti Neuro Solutions	8
Bioplate Inc	5
Fin-Ceramica Faenza SpA	5
KLS-Martin L.P.	5
Synthes (USA) Products LLC	5
Aesculap Inc	3
Ikonos Corp.	2
Kelyniam Global, Inc.	2
Meticuly Co., Ltd.	2
Osteosymbionics, LLC	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 43 companies shown, in name order