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FDA 510(k) Application Details - K182584
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
More FDA Info for this Device
510(K) Number
K182584
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
Cheryl Allen
Other 510(k) Applications for this Contact
Regulation Number
888.3080
More FDA Info for this Regulation Number
Classification Product Code
MAX
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More FDA Info for this Product Code
Date Received
09/20/2018
Decision Date
12/10/2018
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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