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758
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1662
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117
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82
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2340
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390
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139
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Powered Laser Surgical Instrument
278
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System, Image Processing,...
263
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Automated Radiological Image...
246
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Electrosurgical, Cutting &...
231
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System, Imaging, Pulsed Doppler,...
230
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Plate, Fixation, Bone
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
165
MAX
Intervertebral Fusion Device...
159
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Orthogem Limited
Medical Device Manufacturer
·
GB , Nottingham
Orthogem Limited - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2007
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Orthogem Limited
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
Apr 21, 2011
TRIPORE TDD (HA), TRIPORE TDD (BP90), TRIPORE TDD (BP15)
K110787
·
MQV
Orthopedic
·
31d
Cleared
Jul 13, 2007
TRIPORE, MODELS HA, BP90, BP15
K070132
·
MQV
Orthopedic
·
178d
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Orthopedic
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