510k
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1357
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333
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1051
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194
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805
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1771
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1195
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120
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84
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419
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760
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333
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209
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2417
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44
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405
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1964
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142
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Powered Laser Surgical Instrument
288
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System, Image Processing,...
280
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Electrosurgical, Cutting &...
251
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Automated Radiological Image...
250
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System, Imaging, Pulsed Doppler,...
239
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Plate, Fixation, Bone
235
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Polymer Patient Examination Glove
200
OLO
Orthopedic Stereotaxic Instrument
198
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Abutment, Implant, Dental,...
187
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Thoracolumbosacral Pedicle Screw...
167
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Advanced Spine Technology, Inc.
Medical Device Manufacturer
·
US , Hayward , CA
Advanced Spine Technology, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
3 cleared
·
Since 1995
4
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Advanced Spine Technology, Inc.
Orthopedic
✕
4
devices
1-4 of 4
Filters
Cleared
Oct 05, 2006
UNIVERSAL SPINAL ANTERIOR LOCKING PLATE SYSTEM
K062686
·
KWQ
Orthopedic
·
27d
Cleared
Jun 07, 2000
WINDOW CERVICAL DYNAMIC PLATE SYSTEM
K993066
·
KWQ
Orthopedic
·
349d
Cleared
Feb 28, 2000
TRIPLE-FIX SPINAL FIXATION SYSTEM
K992147
·
MNI
Orthopedic
·
249d
Cleared
Nov 21, 1995
AMSET R-F SYSTEM
K951266
·
MNH
Orthopedic
·
245d
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4
Orthopedic
4