DEVICE CLASS
Class II
REGULATION
21 CFR 882.5275
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
K260245KLISBio S.r.l. · 510k2026-04-09
K253363Auxilium Biotechnologies, Inc. · 510k2026-01-17
K251505Alafair Biosciences · 510k2025-07-22
K251175Alafair Biosciences · 510k2025-07-17
K242113Biocircuit Technologies, Inc. · 510k2025-04-02
K243889Orthocell, Ltd. · 510k2025-04-02
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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