510k
Database
Specialties
Anesthesiology
483
Cardiovascular
1461
Chemistry
339
Dental
1159
Ear, Nose, Throat
215
Gastroenterology & Urology
849
General & Plastic Surgery
1915
General Hospital
1455
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
432
Neurology
826
Obstetrics & Gynecology
364
Ophthalmic
242
Orthopedic
2514
Pathology
49
Physical Medicine
443
Radiology
2083
Toxicology
147
Categories
GEX
Powered Laser Surgical Instrument
313
LLZ
System, Image Processing,...
307
LZA
Polymer Patient Examination Glove
282
GEI
Electrosurgical, Cutting &...
263
QIH
Automated Radiological Image...
257
HRS
Plate, Fixation, Bone
247
IYN
System, Imaging, Pulsed Doppler,...
247
OLO
Orthopedic Stereotaxic Instrument
206
NHA
Abutment, Implant, Dental,...
197
MAX
Intervertebral Fusion Device...
174
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Osteo-Technology Intl., Inc.
Medical Device Manufacturer
·
US , Timonium , MD
Osteo-Technology Intl., Inc. - FDA 510(k) Cleared Devices
3 submissions
·
2 cleared
·
Since 1993
3
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Osteo-Technology Intl., Inc.
Orthopedic
✕
3
devices
1-3 of 3
Filters
Cleared
Aug 07, 1995
REPLICA TOTAL HIP SYSTEM
K951741
·
LPH
Orthopedic
·
129d
Cleared
Mar 07, 1994
BIOMETRIC TOTAL HIP SYSTEM
K935012
·
JDI
Orthopedic
·
138d
Cleared
Jul 13, 1993
OTI EUROPEAN COMPRESSION SYSTEM
K925571
·
HRS
Orthopedic
·
252d
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3
Orthopedic
3