510k
Database
Specialties
Anesthesiology
338
Cardiovascular
1073
Chemistry
272
Dental
822
Ear, Nose, Throat
149
Gastroenterology & Urology
637
General & Plastic Surgery
1338
General Hospital
770
Hematology
100
Immunology
72
Medical Genetics
1
Microbiology
367
Neurology
589
Obstetrics & Gynecology
247
Ophthalmic
155
Orthopedic
2063
Pathology
40
Physical Medicine
311
Radiology
1591
Toxicology
132
Categories
GEX
Powered Laser Surgical Instrument
231
HRS
Plate, Fixation, Bone
211
IYN
System, Imaging, Pulsed Doppler,...
209
QIH
Automated Radiological Image...
208
LLZ
System, Image Processing,...
199
GEI
Electrosurgical, Cutting &...
186
OLO
Orthopedic Stereotaxic Instrument
170
NHA
Abutment, Implant, Dental,...
161
MAX
Intervertebral Fusion Device...
138
NKB
Thoracolumbosacral Pedicle Screw...
138
Browse all 339 categories →
Search
Reports
About
Home
Medtronic Sofamor Danek USA, Inc.
Medical Device Manufacturer
·
US , Memphis , TN
Medtronic Sofamor Danek USA, Inc. - FDA 510(k) Cleared Devices
170 submissions
·
159 cleared
·
Since 2000
170
Total
159
Cleared
0
Denied
FDA 510(k) Regulatory Record - Medtronic Sofamor Danek USA, Inc.
Neurology
✕
2
devices
1-2 of 2
Filters
Cleared
Oct 04, 2018
POWEREASE System
K182436
·
HBE
Neurology
·
27d
Cleared
Jan 11, 2013
POWEREASE SYSTEM
K123270
·
HBE
Neurology
·
84d
Filters
Filter by Specialty
All
170
Orthopedic
155
Dental
6
General Hospital
4
General & Plastic Surgery
2
Neurology
2
Radiology
1