510k
Database
Specialties
Anesthesiology
452
Cardiovascular
1377
Chemistry
334
Dental
1067
Ear, Nose, Throat
196
Gastroenterology & Urology
816
General & Plastic Surgery
1800
General Hospital
1235
Hematology
122
Immunology
85
Medical Genetics
7
Microbiology
420
Neurology
769
Obstetrics & Gynecology
339
Ophthalmic
215
Orthopedic
2429
Pathology
45
Physical Medicine
412
Radiology
1988
Toxicology
143
Categories
GEX
Powered Laser Surgical Instrument
294
LLZ
System, Image Processing,...
285
GEI
Electrosurgical, Cutting &...
254
QIH
Automated Radiological Image...
252
IYN
System, Imaging, Pulsed Doppler,...
242
HRS
Plate, Fixation, Bone
236
LZA
Polymer Patient Examination Glove
207
OLO
Orthopedic Stereotaxic Instrument
199
NHA
Abutment, Implant, Dental,...
187
MAX
Intervertebral Fusion Device...
168
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Spinal Concepts, Inc.
Medical Device Manufacturer
·
US , Austin , TX
Spinal Concepts, Inc. - FDA 510(k) Cleared Devices
33 submissions
·
28 cleared
·
Since 1997
33
Total
28
Cleared
0
Denied
FDA 510(k) Regulatory Record - Spinal Concepts, Inc.
Neurology
✕
1
devices
1-1 of 1
Filters
Cleared
Apr 15, 2005
HARMONY PORT SYSTEM, MODEL 1907 SERIES
K050706
·
GZT
Neurology
·
28d
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33
Orthopedic
32
Neurology
1