510k
Database
Specialties
Anesthesiology
199
Cardiovascular
723
Chemistry
186
Dental
450
Ear, Nose, Throat
86
Gastroenterology & Urology
383
General & Plastic Surgery
751
General Hospital
462
Hematology
75
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61
Medical Genetics
1
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273
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289
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112
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75
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1465
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26
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146
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1069
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93
Categories
IYN
System, Imaging, Pulsed Doppler,...
162
HRS
Plate, Fixation, Bone
150
OLO
Orthopedic Stereotaxic Instrument
128
LLZ
System, Image Processing,...
122
GEX
Powered Laser Surgical Instrument
122
QIH
Automated Radiological Image...
107
GEI
Electrosurgical, Cutting &...
104
NHA
Abutment, Implant, Dental,...
103
MAX
Intervertebral Fusion Device...
96
MBI
Fastener, Fixation,...
93
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Arrowhead De, LLC
Medical Device Manufacturer
·
US , Collierville , TN
Arrowhead De, LLC - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2017
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Arrowhead De, LLC
Orthopedic
✕
3
devices
1-3 of 3
Filters
Cleared
Sep 22, 2020
Accessories for the SixFix® Hexapod Fixator
K200123
·
KTT
Orthopedic
·
245d
Cleared
May 14, 2019
SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)
K190069
·
KTT
Orthopedic
·
119d
Cleared
Feb 21, 2017
Arrowhead Mini-Rail Fixator
K162032
·
KTT
Orthopedic
·
214d
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3
Orthopedic
3