510k
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Anesthesiology
144
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584
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167
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327
Ear, Nose, Throat
68
Gastroenterology & Urology
297
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542
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387
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67
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58
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0
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236
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175
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70
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53
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1308
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19
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90
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890
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88
Categories
IYN
System, Imaging, Pulsed Doppler,...
152
HRS
Plate, Fixation, Bone
138
OLO
Orthopedic Stereotaxic Instrument
118
LLZ
System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
87
MBI
Fastener, Fixation,...
85
MAX
Intervertebral Fusion Device...
84
LNH
System, Nuclear Magnetic...
84
NKB
Thoracolumbosacral Pedicle Screw...
83
JAK
System, X-ray, Tomography, Computed
79
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Paradigm Spine
Medical Device Manufacturer
·
US , New York , NY
Paradigm Spine - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2008
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Paradigm Spine
Orthopedic
✕
3
devices
1-3 of 3
Filters
Cleared
Jan 27, 2022
Fortilink with TiPlus Technology
K213493
·
ODP
Orthopedic
·
87d
Cleared
Jul 02, 2008
ORTHOBIOM SPINAL SYSTEM
K071668
·
MNI
Orthopedic
·
379d
Cleared
May 02, 2008
DSS STABILIZATION SYSTEM
K080963
·
NQP
Orthopedic
·
28d
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3
Orthopedic
3