510k
Database
Specialties
Anesthesiology
473
Cardiovascular
1427
Chemistry
335
Dental
1124
Ear, Nose, Throat
209
Gastroenterology & Urology
837
General & Plastic Surgery
1885
General Hospital
1418
Hematology
125
Immunology
87
Medical Genetics
8
Microbiology
424
Neurology
810
Obstetrics & Gynecology
359
Ophthalmic
235
Orthopedic
2469
Pathology
49
Physical Medicine
433
Radiology
2055
Toxicology
145
Categories
GEX
Powered Laser Surgical Instrument
305
LLZ
System, Image Processing,...
304
LZA
Polymer Patient Examination Glove
272
GEI
Electrosurgical, Cutting &...
260
QIH
Automated Radiological Image...
255
IYN
System, Imaging, Pulsed Doppler,...
246
HRS
Plate, Fixation, Bone
244
OLO
Orthopedic Stereotaxic Instrument
203
NHA
Abutment, Implant, Dental,...
191
MAX
Intervertebral Fusion Device...
171
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Orthotec, Inc.
Medical Device Manufacturer
·
US , Pleasant Hill , CA
Orthotec, Inc. - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 1998
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Orthotec, Inc.
Orthopedic
✕
1
devices
1-1 of 1
Filters
Cleared
Dec 18, 1998
SCS SPINAL SYSTEM
K983353
·
KWP
Orthopedic
·
86d
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Orthopedic
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