510k
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451
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1370
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334
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1061
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195
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812
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1790
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1222
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121
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84
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7
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420
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767
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337
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214
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2429
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44
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411
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1983
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143
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Powered Laser Surgical Instrument
293
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System, Image Processing,...
284
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Electrosurgical, Cutting &...
254
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Automated Radiological Image...
251
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System, Imaging, Pulsed Doppler,...
242
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Plate, Fixation, Bone
236
LZA
Polymer Patient Examination Glove
207
OLO
Orthopedic Stereotaxic Instrument
199
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Abutment, Implant, Dental,...
187
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Intervertebral Fusion Device...
168
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Small Bone Innovations, LLC
Medical Device Manufacturer
·
US , New York , NY
Small Bone Innovations, LLC - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2005
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Small Bone Innovations, LLC
Orthopedic
✕
4
devices
1-4 of 4
Filters
Cleared
Nov 07, 2005
SBI AUTOFIX
K052576
·
HWC
Orthopedic
·
49d
Cleared
Sep 06, 2005
SBI WRISTFIT
K051747
·
HRS
Orthopedic
·
69d
Cleared
Aug 10, 2005
SBI K-WIRES
K051605
·
HTY
Orthopedic
·
55d
Cleared
Apr 26, 2005
SBI HAND FIXATION SYSTEM (TM)
K050462
·
HRS
Orthopedic
·
62d
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4
Orthopedic
4