510k
Database
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Anesthesiology
538
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1656
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360
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1323
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244
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957
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2176
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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
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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
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System, Image Processing,...
382
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358
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Powered Laser Surgical Instrument
351
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301
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System, Imaging, Pulsed Doppler,...
284
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Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
214
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Spinal Resources, Inc.
Medical Device Manufacturer
·
US , Indian Harbour Beach , FL
Spinal Resources, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2016
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Spinal Resources, Inc.
Orthopedic
✕
4
devices
1-4 of 4
Filters
Cleared
Jan 13, 2026
Swedge™ Pedicle Screw Fixation System Bezier Rod
K252461
·
NKB
Orthopedic
·
161d
Cleared
Mar 23, 2023
Swedge™ Pedicle Screw Fixation System
K230482
·
NKB
Orthopedic
·
29d
Cleared
Jun 26, 2017
Swedge™ Pedicle Screw Fixation System
K170045
·
NKB
Orthopedic
·
172d
Cleared
Mar 09, 2016
S-Wire
K152662
·
HTY
Orthopedic
·
174d
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Orthopedic
4