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FDA 510(k) Application Details - K130641
Device Classification Name
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510(K) Number
K130641
Device Name
LOGIC STAND-ALONE INTERVERTEBRAL BODY FUSION DEVICE
Applicant
BINDER BIOMEDICAL, INC
1951 NW 7TH AVENUE, STE 13135
MIAMI, FL 33136 US
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Contact
LAWRENCE BINDER
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Regulation Number
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Classification Product Code
OVD
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Date Received
03/11/2013
Decision Date
09/13/2013
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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