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173
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1552
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112
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79
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395
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673
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292
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180
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2202
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42
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362
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1781
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137
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Powered Laser Surgical Instrument
256
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239
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232
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222
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218
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Plate, Fixation, Bone
217
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Orthopedic Stereotaxic Instrument
182
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Abutment, Implant, Dental,...
169
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Thoracolumbosacral Pedicle Screw...
150
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Intervertebral Fusion Device...
146
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Biomet Spine, LLC
Medical Device Manufacturer
·
US , Broomfield , CO
Biomet Spine, LLC - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2014
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Biomet Spine, LLC
Orthopedic
✕
4
devices
1-4 of 4
Filters
Cleared
Jan 21, 2016
Biomet Spine Fusion System
K153695
·
MAX
Orthopedic
·
29d
Cleared
Jul 31, 2015
Biomet Spine Fusion System
K151483
·
MAX
Orthopedic
·
59d
Cleared
Mar 12, 2015
Biomet Spine Fusion System
K142634
·
MAX
Orthopedic
·
176d
Cleared
Sep 25, 2014
POLARIS SPINAL SYSTEM - HA COATED
K141804
·
NKB
Orthopedic
·
84d
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4
Orthopedic
4