← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

MBI — Fastener, Fixation, Nondegradable, Soft Tissue

DEVICE CLASS
Class II
REGULATION
21 CFR 888.3040
MEDICAL SPECIALTY
Orthopedic
REVIEW PANEL
OR
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
52
510(K)/PMA CLEARANCES
510k: 52
0
RECALL ENTRIES

Recent clearances

K261968Smith & Nephew, Inc. · 510k2026-07-09
K260018Arthrex, Inc. · 510k2026-06-26
K253130ZheJiang Decans Medical Devices Co., Ltd. · 510k2026-05-27
K261363CONMED Corporation · 510k2026-05-13
K253027Ortobio S.A. · 510k2026-05-06
K252635ArthroTAK, LLC · 510k2026-05-01
K260921Tigon Medical · 510k2026-04-21
K260561Arthrex, Inc. · 510k2026-03-20

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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