510k
Database
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Anesthesiology
140
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577
Chemistry
167
Dental
324
Ear, Nose, Throat
68
Gastroenterology & Urology
294
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534
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380
Hematology
67
Immunology
58
Medical Genetics
0
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234
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173
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67
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52
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1301
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18
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88
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885
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88
Categories
IYN
System, Imaging, Pulsed Doppler,...
152
HRS
Plate, Fixation, Bone
135
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
87
MBI
Fastener, Fixation,...
85
MAX
Intervertebral Fusion Device...
84
NKB
Thoracolumbosacral Pedicle Screw...
83
LNH
System, Nuclear Magnetic...
83
JAK
System, X-ray, Tomography, Computed
79
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Biocore9, LLC
Medical Device Manufacturer
·
US , Whippany , NJ
Biocore9, LLC - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2020
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Biocore9, LLC
Orthopedic
✕
3
devices
1-3 of 3
Filters
Cleared
May 17, 2022
Biocore9 Acetabular Cup System
K212761
·
LPH
Orthopedic
·
259d
Cleared
Jan 19, 2021
Biocore9 Femoral Head Resurfacing Component
K201219
·
KXA
Orthopedic
·
258d
Cleared
May 15, 2020
Biocore9 Humeral Resurfacing System
K193122
·
HSD
Orthopedic
·
185d
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Orthopedic
3