510k
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183
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114
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82
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2317
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43
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382
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1862
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139
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GEX
Powered Laser Surgical Instrument
275
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System, Image Processing,...
259
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242
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System, Imaging, Pulsed Doppler,...
229
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Plate, Fixation, Bone
228
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Electrosurgical, Cutting &...
227
OLO
Orthopedic Stereotaxic Instrument
188
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Abutment, Implant, Dental,...
176
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Polymer Patient Examination Glove
160
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Thoracolumbosacral Pedicle Screw...
158
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Sintea Plastek, LLC
Medical Device Manufacturer
·
US , Miami Beach , FL
Sintea Plastek, LLC - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2011
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sintea Plastek, LLC
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
Apr 25, 2012
SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS
K112611
·
MNI
Orthopedic
·
231d
Cleared
Jul 21, 2011
DSC/ALF SPINAL SYSTEM
K101886
·
MQP
Orthopedic
·
380d
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Orthopedic
2