510k
Database
Specialties
Anesthesiology
417
Cardiovascular
1261
Chemistry
311
Dental
958
Ear, Nose, Throat
181
Gastroenterology & Urology
750
General & Plastic Surgery
1626
General Hospital
1013
Hematology
114
Immunology
80
Medical Genetics
6
Microbiology
405
Neurology
703
Obstetrics & Gynecology
311
Ophthalmic
189
Orthopedic
2289
Pathology
43
Physical Medicine
379
Radiology
1841
Toxicology
138
Categories
GEX
Powered Laser Surgical Instrument
272
LLZ
System, Image Processing,...
256
QIH
Automated Radiological Image...
241
IYN
System, Imaging, Pulsed Doppler,...
226
GEI
Electrosurgical, Cutting &...
226
HRS
Plate, Fixation, Bone
225
OLO
Orthopedic Stereotaxic Instrument
188
NHA
Abutment, Implant, Dental,...
173
NKB
Thoracolumbosacral Pedicle Screw...
155
LZA
Polymer Patient Examination Glove
153
Browse all 339 categories →
Search
Reports
About
Home
Orthofix
Medical Device Manufacturer
·
US , Lweisville , TX
Orthofix - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2012
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Orthofix
Orthopedic
✕
3
devices
1-3 of 3
Filters
Cleared
Mar 28, 2013
FIREBIRD SPINAL FIXATION SYSTEM
K130176
·
NKB
Orthopedic
·
62d
Cleared
Dec 03, 2012
FIREBIRD SPINAL FIXATION SYSTEM, PHOENIX MIS SPINAL FIXATION SYSTEM
K122901
·
NKB
Orthopedic
·
73d
Cleared
Nov 29, 2012
CONSTRUX MINI PEEK TI SPACER SYSTEM
K121649
·
ODP
Orthopedic
·
177d
Filters
Filter by Specialty
All
3
Orthopedic
3