510k
Database
Specialties
Anesthesiology
204
Cardiovascular
739
Chemistry
187
Dental
465
Ear, Nose, Throat
91
Gastroenterology & Urology
394
General & Plastic Surgery
772
General Hospital
475
Hematology
77
Immunology
64
Medical Genetics
1
Microbiology
277
Neurology
301
Obstetrics & Gynecology
116
Ophthalmic
78
Orthopedic
1477
Pathology
26
Physical Medicine
152
Radiology
1091
Toxicology
93
Categories
IYN
System, Imaging, Pulsed Doppler,...
167
HRS
Plate, Fixation, Bone
151
OLO
Orthopedic Stereotaxic Instrument
131
GEX
Powered Laser Surgical Instrument
126
LLZ
System, Image Processing,...
124
QIH
Automated Radiological Image...
111
NHA
Abutment, Implant, Dental,...
105
GEI
Electrosurgical, Cutting &...
105
MAX
Intervertebral Fusion Device...
96
NKB
Thoracolumbosacral Pedicle Screw...
93
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A.M. Surgical, Inc.
Medical Device Manufacturer
·
US , Great Neck , NY
A.M. Surgical, Inc. - FDA 510(k) Cleared Devices
6 submissions
·
6 cleared
·
Since 1998
6
Total
6
Cleared
0
Denied
FDA 510(k) cleared devices by A.M. Surgical, Inc.
Orthopedic
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 16, 2019
SECURE Screw
K191771
·
HWC
Orthopedic
·
106d
Cleared
May 18, 2018
A.M. Surgical Intramedullary Fixation Device
K180087
·
HTY
Orthopedic
·
126d
Cleared
Oct 07, 2004
A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM
K042458
·
LXT
Orthopedic
·
27d
Filters
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6
Orthopedic
3
General & Plastic Surgery
3