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FDA 510(k) Application Details - K093015
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
More FDA Info for this Device
510(K) Number
K093015
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant
BINDER BIOMEDICAL, INC
2385 NW EXECUTIVE CENTER DRIVE
SUITE 100
BOCA RATON, FL 33431 US
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Contact
LAWRENCE BINDER
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
09/29/2009
Decision Date
02/25/2010
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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