510k
Database
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132
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568
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162
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313
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68
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287
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513
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370
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67
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56
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0
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232
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163
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61
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49
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1289
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18
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85
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866
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88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
133
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Orthopedic Stereotaxic Instrument
117
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System, Image Processing,...
99
MBI
Fastener, Fixation,...
85
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Abutment, Implant, Dental,...
84
LNH
System, Nuclear Magnetic...
83
MAX
Intervertebral Fusion Device...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Pro Surgical, Inc.
Medical Device Manufacturer
·
US , Encinitas , CA
Pro Surgical, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2024
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Pro Surgical, Inc.
Orthopedic
✕
3
devices
1-3 of 3
Filters
Cleared
Jun 24, 2025
ProAM ALIF System
K251644
·
OVD
Orthopedic
·
26d
Cleared
Nov 20, 2024
ProAM ACDF System
K242517
·
OVE
Orthopedic
·
89d
Cleared
May 03, 2024
ProAM ALIF System
K240126
·
OVD
Orthopedic
·
108d
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3
Orthopedic
3