510k
Database
Specialties
Anesthesiology
133
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568
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163
Dental
313
Ear, Nose, Throat
68
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288
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515
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372
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67
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56
Medical Genetics
0
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232
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167
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61
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49
Orthopedic
1292
Pathology
18
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86
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868
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88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
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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Zsfab, Inc.
Medical Device Manufacturer
·
US , Cambridge , MA
Zsfab, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2021
4
Total
4
Cleared
0
Denied
FDA 510(k) cleared devices by Zsfab, Inc.
Orthopedic
✕
4
devices
1-4 of 4
Filters
Cleared
Nov 25, 2025
ZSFab Lumbar Interbody System
K252610
·
MAX
Orthopedic
·
99d
Cleared
Aug 18, 2023
ZSFab Cervical Interbody System
K232150
·
ODP
Orthopedic
·
30d
Cleared
Oct 14, 2022
ZSFab Lumbar Interbody System
K221858
·
MAX
Orthopedic
·
109d
Cleared
Jan 07, 2021
ZSFab Cervical Interbody System
K202488
·
ODP
Orthopedic
·
129d
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Orthopedic
4