510k
Database
Specialties
Anesthesiology
386
Cardiovascular
1201
Chemistry
295
Dental
896
Ear, Nose, Throat
167
Gastroenterology & Urology
709
General & Plastic Surgery
1526
General Hospital
907
Hematology
109
Immunology
78
Medical Genetics
1
Microbiology
392
Neurology
664
Obstetrics & Gynecology
285
Ophthalmic
177
Orthopedic
2194
Pathology
42
Physical Medicine
357
Radiology
1752
Toxicology
137
Categories
GEX
Powered Laser Surgical Instrument
253
QIH
Automated Radiological Image...
231
LLZ
System, Image Processing,...
227
IYN
System, Imaging, Pulsed Doppler,...
221
HRS
Plate, Fixation, Bone
217
GEI
Electrosurgical, Cutting &...
213
OLO
Orthopedic Stereotaxic Instrument
182
NHA
Abutment, Implant, Dental,...
169
NKB
Thoracolumbosacral Pedicle Screw...
149
MAX
Intervertebral Fusion Device...
146
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Medtronic Sofamor Danek
Medical Device Manufacturer
·
US , Memphis , TN
Medtronic Sofamor Danek - FDA 510(k) Cleared Devices
154 submissions
·
147 cleared
·
Since 2002
154
Total
147
Cleared
0
Denied
FDA 510(k) Regulatory Record - Medtronic Sofamor Danek
Dental
✕
4
devices
1-4 of 4
Filters
Cleared
Jan 09, 2009
MASTERGRAFT RESORBABLE CERAMIC GRANULES
K082917
·
LYC
Dental
·
101d
Cleared
Nov 10, 2008
PROGENIX
K082463
·
NUN
Dental
·
75d
Cleared
Sep 17, 2008
MASTERGRAFT PUTTY
K081784
·
LYC
Dental
·
85d
Cleared
May 13, 2008
PROGENIX DBM PUTTY
K080462
·
NUN
Dental
·
83d
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154
Orthopedic
147
Dental
4
General & Plastic Surgery
2
Neurology
1