← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
GXN — Plate, Cranioplasty, Preformed, Non-Alterable
DEVICE CLASS
Class II
REGULATION
21 CFR 882.5330
MEDICAL SPECIALTY
Neurology
REVIEW PANEL
NE
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
6
510(K)/PMA CLEARANCES
510k: 6
0
RECALL ENTRIES
Recent clearances
K260709Longeviti Neuro Solutions · 510k2026-06-25
K253116The Surgeon General, Department of the Army (TSG-DA) · 510k2026-06-18
K252251CG Bio Co., Ltd. · 510k2026-04-09
K252958Meticuly Co., Ltd. · 510k2026-01-14
K243715Synthes GmbH · 510k2025-11-12
K252573KLS-Martin L.P. · 510k2025-11-10
Related on SPEQ
Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
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