510k
Database
Specialties
Anesthesiology
410
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1240
Chemistry
309
Dental
938
Ear, Nose, Throat
180
Gastroenterology & Urology
728
General & Plastic Surgery
1591
General Hospital
985
Hematology
113
Immunology
80
Medical Genetics
6
Microbiology
400
Neurology
692
Obstetrics & Gynecology
298
Ophthalmic
184
Orthopedic
2245
Pathology
43
Physical Medicine
371
Radiology
1812
Toxicology
138
Categories
GEX
Powered Laser Surgical Instrument
261
LLZ
System, Image Processing,...
255
QIH
Automated Radiological Image...
236
IYN
System, Imaging, Pulsed Doppler,...
224
GEI
Electrosurgical, Cutting &...
222
HRS
Plate, Fixation, Bone
220
OLO
Orthopedic Stereotaxic Instrument
184
NHA
Abutment, Implant, Dental,...
169
NKB
Thoracolumbosacral Pedicle Screw...
151
MAX
Intervertebral Fusion Device...
149
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Mazor Surgical Technologies , Ltd.
Medical Device Manufacturer
·
IL , Kfar Saba
Mazor Surgical Technologies , Ltd. - FDA 510(k) Cleared Devices
7 submissions
·
7 cleared
·
Since 2004
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Mazor Surgical Technologies , Ltd.
Neurology
✕
4
devices
1-4 of 4
Filters
Cleared
May 23, 2008
SPINEASSIST SYSTEM
K073467
·
HAW
Neurology
·
165d
Cleared
Aug 23, 2007
SPINEASSIST SYSTEM
K063607
·
HAW
Neurology
·
262d
Cleared
Sep 08, 2005
SPINEASSIST DEVICE WITH ADDITIONAL ACCESSORIES
K051676
·
HAW
Neurology
·
77d
Cleared
Jan 07, 2004
SPINEASSIST DEVICE
K033413
·
HAW
Neurology
·
72d
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7
Neurology
4
Radiology
2
Orthopedic
1