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FDA 510(k) Application Details - K150061
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
More FDA Info for this Device
510(K) Number
K150061
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant
Spinal Elements Inc.
3115 Melrose Dr.,Suite 200
Carlsbad, CA 92010 US
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Contact
Julie Lamothe
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
01/13/2015
Decision Date
05/19/2015
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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