510k
Database
Specialties
Anesthesiology
201
Cardiovascular
731
Chemistry
187
Dental
458
Ear, Nose, Throat
87
Gastroenterology & Urology
387
General & Plastic Surgery
757
General Hospital
466
Hematology
77
Immunology
62
Medical Genetics
1
Microbiology
274
Neurology
293
Obstetrics & Gynecology
113
Ophthalmic
76
Orthopedic
1468
Pathology
26
Physical Medicine
150
Radiology
1078
Toxicology
93
Categories
IYN
System, Imaging, Pulsed Doppler,...
164
HRS
Plate, Fixation, Bone
150
OLO
Orthopedic Stereotaxic Instrument
129
LLZ
System, Image Processing,...
123
GEX
Powered Laser Surgical Instrument
122
QIH
Automated Radiological Image...
109
GEI
Electrosurgical, Cutting &...
104
NHA
Abutment, Implant, Dental,...
104
MAX
Intervertebral Fusion Device...
96
MBI
Fastener, Fixation,...
93
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Back 2 Basics Direct, LLC
Medical Device Manufacturer
·
US , Independence , OH
Back 2 Basics Direct, LLC - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2015
4
Total
4
Cleared
0
Denied
FDA 510(k) cleared devices by Back 2 Basics Direct, LLC
Orthopedic
✕
4
devices
1-4 of 4
Filters
Cleared
May 12, 2020
Dymaxeon Spine System
K192930
·
NKB
Orthopedic
·
208d
Cleared
Sep 26, 2019
eCarbon IBDs
K191537
·
ODP
Orthopedic
·
108d
Cleared
May 22, 2017
Dymaxeon Spine System
K170989
·
NKB
Orthopedic
·
49d
Cleared
Jun 15, 2015
Dymaxeon Spine System
K150184
·
NKB
Orthopedic
·
139d
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Orthopedic
4