← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

HSB — Rod, Fixation, Intramedullary And Accessories

DEVICE CLASS
Class II
REGULATION
21 CFR 888.3020
MEDICAL SPECIALTY
Orthopedic
REVIEW PANEL
OR
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
34
510(K)/PMA CLEARANCES
510k: 34
0
RECALL ENTRIES

Recent clearances

K261481Stryker GmbH · 510k2026-06-29
K253080Suzhou and Science & Technology Development Corp. · 510k2026-06-18
K261651NuVasive Specialized Orthopedics · 510k2026-06-18
K253155Beijing Fule Science & Technology Development Co., Ltd. · 510k2026-06-17
K253046ZheJiang Decans Medical Devices Co., Ltd. · 510k2026-06-16
K260146Orthofix Srl · 510k2026-05-19
K253991Orthofix Srl · 510k2026-05-08
K261043Globus Medical, Inc. · 510k2026-04-24

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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