← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

MAI — Fastener, Fixation, Biodegradable, Soft Tissue

DEVICE CLASS
Class II
REGULATION
21 CFR 888.3030
MEDICAL SPECIALTY
Orthopedic
REVIEW PANEL
OR
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
13
510(K)/PMA CLEARANCES
510k: 13
0
RECALL ENTRIES

Recent clearances

K253931Arthrex, Inc. · 510k2026-05-28
K260294Surgical Fusion Technologies GmbH · 510k2026-03-27
K254055OSSIO , Ltd. · 510k2026-02-24
K251680Biocomposites, Ltd. · 510k2026-02-17
K252946Conmed Corporation · 510k2025-10-15
K252022OSSIO , Ltd. · 510k2025-08-19
K251309OSSIO , Ltd. · 510k2025-05-27
K250544Stryker Endoscopy · 510k2025-05-23

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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