510k
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411
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1245
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309
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942
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181
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732
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1593
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989
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113
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80
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302
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2255
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43
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371
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1815
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138
Categories
GEX
Powered Laser Surgical Instrument
261
LLZ
System, Image Processing,...
255
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Automated Radiological Image...
236
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System, Imaging, Pulsed Doppler,...
224
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Electrosurgical, Cutting &...
222
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Plate, Fixation, Bone
222
OLO
Orthopedic Stereotaxic Instrument
185
NHA
Abutment, Implant, Dental,...
169
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Thoracolumbosacral Pedicle Screw...
154
MAX
Intervertebral Fusion Device...
149
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Exactech Sarasota
Medical Device Manufacturer
·
US , Gainesville , FL
Exactech Sarasota - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2011
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Exactech Sarasota
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
Apr 11, 2014
GIBRALT ROD-TO-ROD CROSS CONNECTORS
K140645
·
KWP
Orthopedic
·
29d
Cleared
Apr 14, 2011
OPTERTRAK LOGIC PSC TIBIAL INSERT
K110547
·
JWH
Orthopedic
·
48d
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Orthopedic
2