510k
Database
Specialties
Anesthesiology
133
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569
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164
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313
Ear, Nose, Throat
68
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288
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515
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373
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67
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56
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0
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233
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167
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61
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49
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1292
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18
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86
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870
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88
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IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
134
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Orthopedic Stereotaxic Instrument
117
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System, Image Processing,...
100
MBI
Fastener, Fixation,...
85
NHA
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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Zeta Surgical, Inc.
Medical Device Manufacturer
·
US , Boston , MA
Zeta 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 Zeta Surgical, Inc.
Neurology
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 10, 2025
Zeta Navigation System (ZNS131-US)
K251927
·
SGE
Neurology
·
109d
Cleared
Oct 04, 2024
Zeta Cranial Navigation System (ZNS131-US)
K242351
·
HAW
Neurology
·
57d
Cleared
Jan 10, 2024
Zeta Cranial Navigation System (ZNS131-US)
K233903
·
HAW
Neurology
·
30d
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3
Neurology
3