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FDA 510(k) Application Details - K130863
Device Classification Name
System, Facet Screw Spinal Device
More FDA Info for this Device
510(K) Number
K130863
Device Name
System, Facet Screw Spinal Device
Applicant
SPINAL USA
1835 MARKET STREET, 29TH FLOOR
PHILADELPHIA, PA 19103 US
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Contact
JANICE M HOGAN
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
MRW
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More FDA Info for this Product Code
Date Received
03/28/2013
Decision Date
08/09/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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