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FDA 510(k) Application Details - K150954
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
More FDA Info for this Device
510(K) Number
K150954
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant
INNOVA SPINAL TECHNOLOGIES, LLC
22324 BOYACA AVE
BOCA RATON, FL 33433 US
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Contact
ARMANDO VARELA
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
04/09/2015
Decision Date
05/07/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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