510k
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198
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719
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185
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448
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86
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382
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748
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460
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74
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61
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271
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286
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111
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75
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1463
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26
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145
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1066
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93
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IYN
System, Imaging, Pulsed Doppler,...
161
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Plate, Fixation, Bone
150
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Orthopedic Stereotaxic Instrument
128
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System, Image Processing,...
122
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Powered Laser Surgical Instrument
121
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Automated Radiological Image...
106
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Abutment, Implant, Dental,...
103
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Electrosurgical, Cutting &...
103
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Intervertebral Fusion Device...
96
MBI
Fastener, Fixation,...
93
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Prism Surgical Designs Pty, Ltd.
Medical Device Manufacturer
·
AU , Milton
Prism Surgical Designs Pty, Ltd. - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2020
1
Total
1
Cleared
0
Denied
FDA 510(k) cleared devices by Prism Surgical Designs Pty, Ltd.
Orthopedic
✕
1
devices
1-1 of 1
Filters
Cleared
Dec 22, 2020
Australis Anterior Lumbar Cage System
K202820
·
MAX
Orthopedic
·
89d
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Orthopedic
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