Medical Device Manufacturer · US , Rockville , MD

Orthofix Srl - FDA 510(k) Cleared Devices

38 submissions · 38 cleared · Since 1995

Recent clearances: FITBONE® TRANSPORT AND LENGTHENING SYSTEM, Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA, FitboneTM Trochanteric

38
Total
38
Cleared
0
Denied

FDA 510(k) Regulatory Record - Orthofix Srl Orthopedic ✕

36 devices
1-12 of 36
Cleared May 19, 2026
FITBONE® TRANSPORT AND LENGTHENING SYSTEM
K260146 · HSB
Orthopedic · 119d
Cleared May 08, 2026
Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA
K253991 · HSB
Orthopedic · 147d
Cleared Apr 10, 2025
FitboneTM Trochanteric
K250112 · HSB
Orthopedic · 84d
Cleared Dec 03, 2024
TrueLok Elevate
K242861 · KTT
Orthopedic · 74d
Cleared Jun 18, 2024
Fitbone Trochanteric
K233867 · HSB
Orthopedic · 195d
Cleared May 03, 2024
RODEO Telescopic Nail
K232648 · HSB
Orthopedic · 246d
Cleared Mar 22, 2024
FITBONE® Transport and Lengthening System
K232169 · HSB
Orthopedic · 245d
Cleared Jan 18, 2022
JuniOrtho Plating System™
K213572 · HWC
Orthopedic · 69d
Cleared Nov 05, 2021
TrueLok Evo
K212044 · KTT
Orthopedic · 128d
Cleared Apr 20, 2021
SOLE Medial Column Fusion Plate
K210157 · HRS
Orthopedic · 89d
Cleared May 22, 2020
JPS JuniOrtho Plating System
K200246 · HRS
Orthopedic · 112d
Cleared Jun 07, 2019
RIVAL View Plating Systems and Reduce Fracture Plating Systems
K190388 · HRS
Orthopedic · 108d
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