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FDA 510(k) Application Details - K181621
Device Classification Name
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510(K) Number
K181621
Device Name
Stable-C Interbody System
Applicant
Nexus Spine, LLC
2825 E Cottonwood Parkway, Suite 330
Salt Lake City, UT 84121 US
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Contact
Jared Crocker
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Regulation Number
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Classification Product Code
OVE
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Date Received
06/20/2018
Decision Date
10/19/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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