510k
Database
Specialties
Anesthesiology
471
Cardiovascular
1413
Chemistry
334
Dental
1116
Ear, Nose, Throat
208
Gastroenterology & Urology
833
General & Plastic Surgery
1862
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1360
Hematology
124
Immunology
87
Medical Genetics
7
Microbiology
423
Neurology
804
Obstetrics & Gynecology
354
Ophthalmic
231
Orthopedic
2460
Pathology
48
Physical Medicine
427
Radiology
2037
Toxicology
144
Categories
GEX
Powered Laser Surgical Instrument
301
LLZ
System, Image Processing,...
300
GEI
Electrosurgical, Cutting &...
258
QIH
Automated Radiological Image...
255
IYN
System, Imaging, Pulsed Doppler,...
245
LZA
Polymer Patient Examination Glove
245
HRS
Plate, Fixation, Bone
242
OLO
Orthopedic Stereotaxic Instrument
202
NHA
Abutment, Implant, Dental,...
190
MAX
Intervertebral Fusion Device...
171
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Orthodyne, Inc.
Medical Device Manufacturer
·
US , Orlando , FL
Orthodyne, Inc. - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2001
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Orthodyne, Inc.
Orthopedic
✕
1
devices
1-1 of 1
Filters
Cleared
May 02, 2001
ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR)
K010322
·
HSB
Orthopedic
·
89d
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1
Orthopedic
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