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387
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168
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110
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664
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285
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2194
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360
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1755
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137
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227
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217
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Orthopedic Stereotaxic Instrument
182
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169
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Thoracolumbosacral Pedicle Screw...
149
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Intervertebral Fusion Device...
146
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Orbbo Surgical, LLC
Medical Device Manufacturer
·
US , Los Angeles , CA
Orbbo Surgical, LLC - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2016
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Orbbo Surgical, LLC
Orthopedic
✕
4
devices
1-4 of 4
Filters
Cleared
Apr 07, 2017
Kepler II
K163265
·
ODP
Orthopedic
·
137d
Cleared
Feb 16, 2017
Kepler I Cervical Plate System
K163602
·
KWQ
Orthopedic
·
57d
Cleared
Feb 09, 2017
Hubble I System
K163566
·
NKB
Orthopedic
·
52d
Cleared
Dec 29, 2016
Hubble II
K163180
·
MAX
Orthopedic
·
45d
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4
Orthopedic
4