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FDA 510(k) Application Details - K160976
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
More FDA Info for this Device
510(K) Number
K160976
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant
ALTUS PARTNERS, LLC
5149 WEST CHESTER PIKE
Newtown Square, PA 19073 US
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Contact
Claudia Hill
Other 510(k) Applications for this Contact
Regulation Number
888.3080
More FDA Info for this Regulation Number
Classification Product Code
MAX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/07/2016
Decision Date
01/25/2017
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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