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FDA 510(k) Application Details - K162693
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
More FDA Info for this Device
510(K) Number
K162693
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant
FACETLINK DBA LINKSPINE
101 ROUNDHILL DRIVE
ROCKAWAY, NJ 07866 US
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Contact
MASSIMO CALAFIORE
Other 510(k) Applications for this Contact
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
09/27/2016
Decision Date
03/29/2017
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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