510k
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540
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1663
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362
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1334
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244
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963
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2184
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2043
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126
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97
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8
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466
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963
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433
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274
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2875
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52
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515
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2430
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155
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LZA
Polymer Patient Examination Glove
408
LLZ
System, Image Processing,...
383
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358
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
302
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System, Imaging, Pulsed Doppler,...
296
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Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
219
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Artfx Medical
Medical Device Manufacturer
·
US , Jacksonville , FL
Artfx Medical - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2024
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Artfx Medical
Orthopedic
✕
3
devices
1-3 of 3
Filters
Cleared
Dec 23, 2024
ARTFX Trauma Bone Plate and Screw System
K242939
·
HRS
Orthopedic
·
89d
Cleared
Oct 02, 2024
ARTFX Lumbar PEEK Cages
K240889
·
MAX
Orthopedic
·
184d
Cleared
Jun 28, 2024
ARTFX MEDICAL Cervical PEEK Cages
K240893
·
ODP
Orthopedic
·
88d
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3
Orthopedic
3