510k
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542
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1680
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365
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1338
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249
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975
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2196
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2048
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126
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99
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8
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469
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965
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434
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279
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2940
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52
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515
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2444
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155
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LZA
Polymer Patient Examination Glove
409
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System, Image Processing,...
388
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358
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Powered Laser Surgical Instrument
356
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306
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System, Imaging, Pulsed Doppler,...
299
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Plate, Fixation, Bone
278
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Automated Radiological Image...
276
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Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
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K&J Consulting Corp.
Medical Device Manufacturer
·
US , Lansdale , PA
K&J Consulting Corp. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2023
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - K&J Consulting Corp.
Orthopedic
✕
3
devices
1-3 of 3
Filters
Cleared
Nov 27, 2023
Statera-C™ Spinal System
K233332
·
NKG
Orthopedic
·
59d
Cleared
Oct 24, 2023
Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System
K232586
·
NKB
Orthopedic
·
60d
Cleared
Jul 16, 2023
FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate...
K231460
·
KWQ
Orthopedic
·
58d
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3
Orthopedic
3