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112
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292
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2211
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363
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1791
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137
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257
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245
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233
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222
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219
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217
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Orthopedic Stereotaxic Instrument
182
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Abutment, Implant, Dental,...
169
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Thoracolumbosacral Pedicle Screw...
151
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Intervertebral Fusion Device...
146
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Superdimension, Inc.
Medical Device Manufacturer
·
US , Plymouth , MN
Superdimension, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2011
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Superdimension, Inc.
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
Oct 26, 2012
SUPERDIMENSION NITINOL/GOLD FIDUCIAL MARKER
K120796
·
JAK
Radiology
·
225d
Cleared
Feb 11, 2011
SUPERDIMENSION MARKER DELIVERY KIT
K110093
·
JAK
Radiology
·
30d
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Radiology
2