510k
Database
Specialties
Anesthesiology
478
Cardiovascular
1441
Chemistry
337
Dental
1139
Ear, Nose, Throat
210
Gastroenterology & Urology
841
General & Plastic Surgery
1895
General Hospital
1439
Hematology
125
Immunology
89
Medical Genetics
8
Microbiology
426
Neurology
812
Obstetrics & Gynecology
362
Ophthalmic
238
Orthopedic
2484
Pathology
49
Physical Medicine
439
Radiology
2062
Toxicology
145
Categories
GEX
Powered Laser Surgical Instrument
307
LLZ
System, Image Processing,...
305
LZA
Polymer Patient Examination Glove
278
GEI
Electrosurgical, Cutting &...
261
QIH
Automated Radiological Image...
256
IYN
System, Imaging, Pulsed Doppler,...
246
HRS
Plate, Fixation, Bone
245
OLO
Orthopedic Stereotaxic Instrument
204
NHA
Abutment, Implant, Dental,...
191
MAX
Intervertebral Fusion Device...
172
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Orthopedic Systems, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Orthopedic Systems, Inc. - FDA 510(k) Cleared Devices
95 submissions
·
89 cleared
·
Since 1977
95
Total
89
Cleared
0
Denied
FDA 510(k) Regulatory Record - Orthopedic Systems, Inc.
Ear, Nose, Throat
✕
1
devices
1-1 of 1
Filters
Cleared
Jan 18, 1989
CRUCIOMETER
K884483
·
JZE
Ear, Nose, Throat
·
85d
Filters
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All
95
Orthopedic
38
General & Plastic Surgery
26
Neurology
13
Physical Medicine
12
General Hospital
2
Gastroenterology & Urology
1
Anesthesiology
1
Ear, Nose, Throat
1
Radiology
1