Orthofix, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Orthofix, Inc. - FDA 510(k) Cleared Devices
Recent clearances: PILLAR SA Ti Spacer System (82-XXX), CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CONSTRUX Mini Ti Spacer System, FORZA PEEK Spacer System, FORZA PTC Spacer System, FORZA Ti Spacer System, FORZA XP Expandable Spacer System, Lonestar Cervical Standalone System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, PILLAR SA PTC Spacer System, SKYHAWK Lateral Interbody Fusion System, Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Deformity Spinal Fixation System, Phoenix MIS Spinal Fixation System, Phoenix CDX MIS Spinal Fixation System, JANUS Midline Fixation Screws, Firebird NXG Spinal Fixation System, JANUS Fenestrated Screws), Connector System, FIREBIRD SI Fusion System
57
Total
57
Cleared
0
Denied
Orthofix, Inc. has 57 FDA 510(k) cleared orthopedic devices. Based in Mckinney, US.
Latest FDA clearance: May 2024. Active since 1996.
Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Orthofix, Inc.
57 devices
Cleared
May 28, 2024
PILLAR SA Ti Spacer System (82-XXX)
Orthopedic
70d
Cleared
Aug 31, 2021
CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini...
Orthopedic
89d
Cleared
Jul 30, 2021
Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS),...
Orthopedic
57d
Cleared
Mar 25, 2021
FIREBIRD SI Fusion System
Orthopedic
20d
Cleared
Mar 18, 2021
CONSTRUX Mini Ti Spacer System
Orthopedic
125d
Cleared
Mar 03, 2021
FORZA Ti Spacer System
Orthopedic
86d
Cleared
Nov 18, 2020
FIREBIRD SI Fusion System
Orthopedic
29d
Cleared
Oct 29, 2020
CONSTRUX Mini PEEK Spacer System
Orthopedic
29d
Cleared
Oct 14, 2020
CONSTRUX Mini PTC Spacer System
Orthopedic
30d
Cleared
Sep 15, 2020
FIREBIRD SI Fusion System
Orthopedic
88d
Cleared
Jun 15, 2020
Centurion POCT System
Orthopedic
11d
Cleared
May 01, 2020
O-Genesis Graft Delivery System
General & Plastic Surgery
53d
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