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GEX
Powered Laser Surgical Instrument
253
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231
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221
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217
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214
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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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Restore Surgical, LLC Dba Instratek
Medical Device Manufacturer
·
US , Houston , TX
Restore Surgical, LLC Dba Instratek - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2015
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Restore Surgical, LLC Dba Instratek
Orthopedic
✕
3
devices
1-3 of 3
Filters
Cleared
Feb 10, 2017
EasyClip Xpress
K162321
·
JDR
Orthopedic
·
175d
Cleared
Nov 22, 2016
ToeTac™ 10° Hammertoe Fixation System
K161778
·
HWC
Orthopedic
·
146d
Cleared
Jun 04, 2015
ToeTac Hammertoe Fixation System
K150443
·
HWC
Orthopedic
·
104d
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Orthopedic
3