510k
Database
Specialties
Anesthesiology
483
Cardiovascular
1461
Chemistry
339
Dental
1159
Ear, Nose, Throat
215
Gastroenterology & Urology
849
General & Plastic Surgery
1915
General Hospital
1455
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
432
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825
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364
Ophthalmic
242
Orthopedic
2513
Pathology
49
Physical Medicine
443
Radiology
2081
Toxicology
147
Categories
GEX
Powered Laser Surgical Instrument
313
LLZ
System, Image Processing,...
307
LZA
Polymer Patient Examination Glove
282
GEI
Electrosurgical, Cutting &...
263
QIH
Automated Radiological Image...
257
HRS
Plate, Fixation, Bone
247
IYN
System, Imaging, Pulsed Doppler,...
247
OLO
Orthopedic Stereotaxic Instrument
206
NHA
Abutment, Implant, Dental,...
197
MAX
Intervertebral Fusion Device...
174
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Danek Group, Inc.
Medical Device Manufacturer
·
US , Memphis , TN
Danek Group, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
0 cleared
·
Since 1994
2
Total
0
Cleared
0
Denied
FDA 510(k) Regulatory Record - Danek Group, Inc.
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
Aug 14, 1995
DYNA-LOK ANTERIOR PLATING SYSTEM
K936307
·
MNH
Orthopedic
·
721d
Cleared
Jun 21, 1994
GDLH VARIABLE ANGLE CONNECTOR
K934582
·
KWP
Orthopedic
·
271d
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Orthopedic
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