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FDA 510(k) Application Details - K191537
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Cervical
More FDA Info for this Device
510(K) Number
K191537
Device Name
Intervertebral Fusion Device With Bone Graft, Cervical
Applicant
Back 2 Basics Direct, LLC
6701 Rockside Road, Suite 200
Independence, OH 44131 US
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Contact
Scot Miller
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
06/10/2019
Decision Date
09/26/2019
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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