510k
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331
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1056
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268
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794
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148
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619
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1308
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747
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97
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72
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364
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567
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242
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154
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2038
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38
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309
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1575
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131
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Powered Laser Surgical Instrument
227
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208
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System, Imaging, Pulsed Doppler,...
207
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Automated Radiological Image...
205
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System, Image Processing,...
197
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Electrosurgical, Cutting &...
185
OLO
Orthopedic Stereotaxic Instrument
168
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Abutment, Implant, Dental,...
153
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Intervertebral Fusion Device...
137
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Thoracolumbosacral Pedicle Screw...
135
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Orthosoft, Inc.
Medical Device Manufacturer
·
CA , Montreal, Quebec
Orthosoft, Inc. - FDA 510(k) Cleared Devices
14 submissions
·
14 cleared
·
Since 1998
14
Total
14
Cleared
0
Denied
FDA 510(k) Regulatory Record - Orthosoft, Inc.
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
Sep 13, 2013
CAS PSI KNEE SYSTEM
K131409
·
JWH
Orthopedic
·
121d
Cleared
Apr 05, 2010
CAS FIXATION PIN 3.2 DIA X 180 MM STR, CAS FIXATON PIN 3.2 DIA X 80 MM STR,...
K100599
·
OLO
Orthopedic
·
33d
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14
Neurology
12
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2