510k
Database
Specialties
Anesthesiology
133
Cardiovascular
569
Chemistry
164
Dental
314
Ear, Nose, Throat
68
Gastroenterology & Urology
288
General & Plastic Surgery
516
General Hospital
373
Hematology
67
Immunology
56
Medical Genetics
0
Microbiology
233
Neurology
167
Obstetrics & Gynecology
61
Ophthalmic
49
Orthopedic
1293
Pathology
18
Physical Medicine
86
Radiology
870
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
MBI
Fastener, Fixation,...
85
NHA
Abutment, Implant, Dental,...
84
LNH
System, Nuclear Magnetic...
83
MAX
Intervertebral Fusion Device...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
Browse all 339 categories →
Search
Reports
About
Home
Orthofix US, LLC
Medical Device Manufacturer
·
US , Lweisville , TX
Orthofix US, LLC - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2022
4
Total
4
Cleared
0
Denied
FDA 510(k) cleared devices by Orthofix US, LLC
Orthopedic
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 31, 2025
Firebird SI Navigation System
K252088
·
OLO
Orthopedic
·
121d
Cleared
Feb 11, 2022
3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating...
K211712
·
KWQ
Orthopedic
·
253d
Cleared
Jan 05, 2022
FORZA XP Expandable Spacer System
K213951
·
MAX
Orthopedic
·
19d
Filters
Filter by Specialty
All
4
Orthopedic
3
Radiology
1