510k
Database
Specialties
Anesthesiology
417
Cardiovascular
1255
Chemistry
310
Dental
957
Ear, Nose, Throat
181
Gastroenterology & Urology
746
General & Plastic Surgery
1615
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1002
Hematology
114
Immunology
80
Medical Genetics
6
Microbiology
405
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701
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308
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189
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2271
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43
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378
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1835
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138
Categories
GEX
Powered Laser Surgical Instrument
269
LLZ
System, Image Processing,...
256
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Automated Radiological Image...
238
IYN
System, Imaging, Pulsed Doppler,...
226
GEI
Electrosurgical, Cutting &...
225
HRS
Plate, Fixation, Bone
223
OLO
Orthopedic Stereotaxic Instrument
187
NHA
Abutment, Implant, Dental,...
172
NKB
Thoracolumbosacral Pedicle Screw...
154
LZA
Polymer Patient Examination Glove
153
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Ingen Orthopedics, LLC
Medical Device Manufacturer
·
US , Cranbury , NJ
Ingen Orthopedics, LLC - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2012
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ingen Orthopedics, LLC
Orthopedic
✕
3
devices
1-3 of 3
Filters
Cleared
Aug 28, 2013
SEVIIN FRACTURE SHOULDER
K131277
·
KWS
Orthopedic
·
114d
Cleared
Aug 26, 2013
SEVIIN SURFACE REPLACEMENT SHOULDER
K130635
·
HSD
Orthopedic
·
168d
Cleared
Jul 09, 2012
SEVIIN REVERSE SHOULDER
K120374
·
PHX
Orthopedic
·
154d
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Orthopedic
3