510k
Database
Specialties
Anesthesiology
427
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1296
Chemistry
327
Dental
991
Ear, Nose, Throat
185
Gastroenterology & Urology
765
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1674
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1079
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117
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82
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7
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410
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726
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316
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197
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2345
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44
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390
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1882
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139
Categories
GEX
Powered Laser Surgical Instrument
278
LLZ
System, Image Processing,...
263
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Automated Radiological Image...
246
GEI
Electrosurgical, Cutting &...
236
HRS
Plate, Fixation, Bone
231
IYN
System, Imaging, Pulsed Doppler,...
230
OLO
Orthopedic Stereotaxic Instrument
192
NHA
Abutment, Implant, Dental,...
179
LZA
Polymer Patient Examination Glove
168
NKB
Thoracolumbosacral Pedicle Screw...
160
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Ortho-Pro, LLC
Medical Device Manufacturer
·
US , Round Rock , TX
Ortho-Pro, LLC - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2003
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ortho-Pro, LLC
Orthopedic
✕
4
devices
1-4 of 4
Filters
Cleared
Jan 14, 2011
ORTHOFLEX ROD
K102601
·
KWH
Orthopedic
·
127d
Cleared
Mar 10, 2010
TC PLATING SYSTEM
K094037
·
HRS
Orthopedic
·
70d
Cleared
Sep 16, 2004
ORTHO-PRO CANNULATED BONE SCREWS
K042310
·
HWC
Orthopedic
·
22d
Cleared
Oct 22, 2003
STS SCREW
K032682
·
HWC
Orthopedic
·
54d
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4
Orthopedic
4