510k
Database
Specialties
Anesthesiology
204
Cardiovascular
735
Chemistry
187
Dental
463
Ear, Nose, Throat
91
Gastroenterology & Urology
391
General & Plastic Surgery
767
General Hospital
473
Hematology
77
Immunology
63
Medical Genetics
1
Microbiology
275
Neurology
296
Obstetrics & Gynecology
114
Ophthalmic
76
Orthopedic
1475
Pathology
26
Physical Medicine
152
Radiology
1083
Toxicology
93
Categories
IYN
System, Imaging, Pulsed Doppler,...
167
HRS
Plate, Fixation, Bone
151
OLO
Orthopedic Stereotaxic Instrument
130
GEX
Powered Laser Surgical Instrument
125
LLZ
System, Image Processing,...
123
QIH
Automated Radiological Image...
109
GEI
Electrosurgical, Cutting &...
105
NHA
Abutment, Implant, Dental,...
105
MAX
Intervertebral Fusion Device...
96
MBI
Fastener, Fixation,...
93
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Spine Smith Holdings, LLC
Medical Device Manufacturer
·
US , Austin , TX
Spine Smith Holdings, LLC - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2014
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Spine Smith Holdings, LLC
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
Jan 10, 2020
CorticaLINK Spinal Fusion Platform
K193465
·
NKB
Orthopedic
·
25d
Cleared
Nov 25, 2014
IN:C2 SPINAL FIXATION SYSTME
K141537
·
OVE
Orthopedic
·
168d
Filters
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3
Orthopedic
2
Gastroenterology & Urology
1