510k
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1287
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184
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757
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1659
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116
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82
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316
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2337
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390
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1876
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139
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GEX
Powered Laser Surgical Instrument
278
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System, Image Processing,...
262
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245
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Electrosurgical, Cutting &...
230
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Plate, Fixation, Bone
230
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System, Imaging, Pulsed Doppler,...
230
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Orthopedic Stereotaxic Instrument
191
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Abutment, Implant, Dental,...
178
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Polymer Patient Examination Glove
163
MAX
Intervertebral Fusion Device...
159
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Intelligent Orthopaedics, Ltd.
Medical Device Manufacturer
·
GB , Brierfield, Nelson
Intelligent Orthopaedics, Ltd. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2006
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Intelligent Orthopaedics, Ltd.
Orthopedic
✕
3
devices
1-3 of 3
Filters
Cleared
May 17, 2011
STERILE STORM (R) OPERATING KIT
K111001
·
HWC
Orthopedic
·
36d
Cleared
May 16, 2007
IOS EXTERNAL FIXATOR, MODEL 2-0-0
K070724
·
KTT
Orthopedic
·
62d
Cleared
Jul 18, 2006
STORM OPERATING KIT, MODEL 1-10-0
K061607
·
HTY
Orthopedic
·
39d
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Orthopedic
3