510k
Database
Specialties
Anesthesiology
472
Cardiovascular
1417
Chemistry
334
Dental
1119
Ear, Nose, Throat
209
Gastroenterology & Urology
836
General & Plastic Surgery
1873
General Hospital
1379
Hematology
125
Immunology
87
Medical Genetics
8
Microbiology
424
Neurology
807
Obstetrics & Gynecology
355
Ophthalmic
234
Orthopedic
2467
Pathology
48
Physical Medicine
429
Radiology
2047
Toxicology
145
Categories
GEX
Powered Laser Surgical Instrument
305
LLZ
System, Image Processing,...
304
GEI
Electrosurgical, Cutting &...
258
QIH
Automated Radiological Image...
255
LZA
Polymer Patient Examination Glove
252
IYN
System, Imaging, Pulsed Doppler,...
245
HRS
Plate, Fixation, Bone
243
OLO
Orthopedic Stereotaxic Instrument
203
NHA
Abutment, Implant, Dental,...
190
MAX
Intervertebral Fusion Device...
171
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Osteonics Corp.
Medical Device Manufacturer
·
US , Mchenry , IL
Osteonics Corp. - FDA 510(k) Cleared Devices
178 submissions
·
136 cleared
·
Since 1980
178
Total
136
Cleared
0
Denied
FDA 510(k) Regulatory Record - Osteonics Corp.
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Nov 29, 1995
OSTEONICS INSIGHT KNEE POSITIONING & ALIGNMENT SYSTEM
K953961
·
FWW
General Hospital
·
99d
Cleared
Jun 22, 1993
OSTEONICS MICROSUTERED FEMORAL COMPONENTES
K926201
·
LPH
General Hospital
·
195d
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178
Orthopedic
176
General Hospital
2