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
NKB
Thoracolumbosacral Pedicle Screw...
138
MAX
Intervertebral Fusion Device...
138
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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.
General & Plastic Surgery
✕
2
devices
1-2 of 2
Filters
Cleared
Feb 28, 2024
OsteoCool™ 2.0 RF Ablation System
K233830
·
GEI
General & Plastic Surgery
·
89d
Cleared
Jan 15, 2019
OsteoCool RF Ablation System
K182497
·
GEI
General & Plastic Surgery
·
125d
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170
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155
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6
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4
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2
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2
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1