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FDA 510(k) Application Details - K181115
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Cervical
More FDA Info for this Device
510(K) Number
K181115
Device Name
Intervertebral Fusion Device With Bone Graft, Cervical
Applicant
Innovasis, Inc.
614 East 3900 South
Salt Lake City, UT 84107 US
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Contact
Marshall McCarty
Other 510(k) Applications for this Contact
Regulation Number
888.3080
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Classification Product Code
ODP
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More FDA Info for this Product Code
Date Received
04/27/2018
Decision Date
07/16/2018
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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