510k
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1261
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311
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958
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181
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114
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80
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405
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703
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311
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189
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2288
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43
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379
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1840
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Powered Laser Surgical Instrument
272
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256
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240
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226
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System, Imaging, Pulsed Doppler,...
226
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Plate, Fixation, Bone
225
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Orthopedic Stereotaxic Instrument
188
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Abutment, Implant, Dental,...
173
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Thoracolumbosacral Pedicle Screw...
155
LZA
Polymer Patient Examination Glove
153
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Gold Standard Orthopaedics, LLC
Medical Device Manufacturer
·
US , Louisville , KY
Gold Standard Orthopaedics, LLC - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2007
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Gold Standard Orthopaedics, LLC
Orthopedic
✕
4
devices
1-4 of 4
Filters
Cleared
Mar 11, 2013
GSO GS1 CANNULATED SCREW SYSTEM
K123487
·
MNH
Orthopedic
·
118d
Cleared
Sep 02, 2009
GSO PCT SPINAL SYSTEM
K091359
·
KWP
Orthopedic
·
117d
Cleared
Jul 20, 2007
GSO GS1 SPINAL SYSTEM
K070966
·
KWP
Orthopedic
·
106d
Cleared
Jan 31, 2007
GSO BONE FIXATION FASTENERS
K063589
·
HWC
Orthopedic
·
61d
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Orthopedic
4