510k
Database
Specialties
Anesthesiology
538
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1656
Chemistry
360
Dental
1323
Ear, Nose, Throat
244
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957
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2176
General Hospital
2039
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126
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97
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8
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462
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959
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433
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274
Orthopedic
2844
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52
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515
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2413
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155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
382
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
284
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
214
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Wright Medical
Medical Device Manufacturer
·
US , Memphis , TN
Wright Medical - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2017
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Wright Medical
Orthopedic
✕
3
devices
1-3 of 3
Filters
Cleared
May 11, 2021
DART-FIRE EDGE Cannulated Screw System
K203228
·
HWC
Orthopedic
·
190d
Cleared
May 07, 2021
FuseForce™ Flex Dynamic Compression System
K203832
·
JDR
Orthopedic
·
128d
Cleared
Mar 06, 2017
SALVATION External Fixation System
K162033
·
KTT
Orthopedic
·
227d
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Orthopedic
3