← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

HTY — Pin, Fixation, Smooth

DEVICE CLASS
Class II
REGULATION
21 CFR 888.3040
MEDICAL SPECIALTY
Orthopedic
REVIEW PANEL
OR
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
5
510(K)/PMA CLEARANCES
510k: 5
0
RECALL ENTRIES

Recent clearances

K253325Toetal Solutions · 510k2025-12-29
K252657Nvision Biomedical Technologies, Inc. · 510k2025-09-19
K250315AIRS, Inc. · 510k2025-08-01
K251362OrthoPediatrics Corp. · 510k2025-06-24
K250646Nvision Biomedical Technologies · 510k2025-06-11

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

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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