Orthofix Srl is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Orthofix Srl - FDA 510(k) Cleared Devices
Recent clearances: FITBONE® TRANSPORT AND LENGTHENING SYSTEM, Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA, FitboneTM Trochanteric
38
Total
38
Cleared
0
Denied
Orthofix Srl has 38 FDA 510(k) cleared orthopedic devices. Based in Rockville, US.
Latest FDA clearance: May 2026. Active since 1995.
Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Wagoner Consulting, LLC, Wagoner Consulting Llg and Wagoner Consulting.
FDA 510(k) Regulatory Record - Orthofix Srl
38 devices
Cleared
May 19, 2026
FITBONE® TRANSPORT AND LENGTHENING SYSTEM
Orthopedic
119d
Cleared
May 08, 2026
Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA
Orthopedic
147d
Cleared
Apr 10, 2025
FitboneTM Trochanteric
Orthopedic
84d
Cleared
Dec 19, 2024
OrthoNext Platform System
Radiology
140d
Cleared
Dec 03, 2024
TrueLok Elevate
Orthopedic
74d
Cleared
Jun 18, 2024
Fitbone Trochanteric
Orthopedic
195d
Cleared
May 03, 2024
RODEO Telescopic Nail
Orthopedic
246d
Cleared
Mar 22, 2024
FITBONE® Transport and Lengthening System
Orthopedic
245d
Cleared
Jan 18, 2022
JuniOrtho Plating System™
Orthopedic
69d
Cleared
Nov 05, 2021
TrueLok Evo
Orthopedic
128d
Cleared
Apr 20, 2021
SOLE Medial Column Fusion Plate
Orthopedic
89d
Cleared
Oct 27, 2020
OrthoNext Platform System
Radiology
56d
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