← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

KTT — Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

DEVICE CLASS
Class II
REGULATION
21 CFR 888.3030
MEDICAL SPECIALTY
Orthopedic
REVIEW PANEL
OR
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
17
510(K)/PMA CLEARANCES
510k: 17
0
RECALL ENTRIES

Recent clearances

K254087Synthes (USA) Products, LLC · 510k2026-06-11
K260900Vilex, LLC · 510k2026-04-17
K260112Stabiliz Orthopaedics, Inc. · 510k2026-03-23
K253291Blue Ocean Global · 510k2026-01-20
K253613Paragon 28, Inc. · 510k2025-12-19
K253202Stryker GmbH · 510k2025-12-19
K252555Medusa Orthopedics, LLC · 510k2025-11-25
K252625Response Ortho Solutions, LLC · 510k2025-11-20

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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