510k
Database
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Anesthesiology
133
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569
Chemistry
164
Dental
313
Ear, Nose, Throat
68
Gastroenterology & Urology
288
General & Plastic Surgery
515
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373
Hematology
67
Immunology
56
Medical Genetics
0
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233
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167
Obstetrics & Gynecology
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
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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BioPoly, LLC
Medical Device Manufacturer
·
US , Fort Wayne , IN
BioPoly, LLC - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2021
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by BioPoly, LLC
Orthopedic
✕
3
devices
1-3 of 3
Filters
Cleared
Mar 13, 2024
BioPoly Radial Head Implant
K233592
·
KWI
Orthopedic
·
126d
Cleared
Nov 22, 2022
BioPoly Lesser Toe Hemiarthroplasty Implant
K222964
·
KWD
Orthopedic
·
56d
Cleared
Feb 02, 2021
BioPoly Great Toe Hemiarthroplasty Implant
K203634
·
KWD
Orthopedic
·
53d
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Orthopedic
3