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FDA 510(k) Application Details - K170297
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
More FDA Info for this Device
510(K) Number
K170297
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
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
888.3080
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Classification Product Code
MAX
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More FDA Info for this Product Code
Date Received
01/31/2017
Decision Date
06/27/2017
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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