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FDA 510(k) Application Details - K101284
Device Classification Name
System, Facet Screw Spinal Device
More FDA Info for this Device
510(K) Number
K101284
Device Name
System, Facet Screw Spinal Device
Applicant
NUVASIVE, INC.
7475 LUSK BLVD
SAN DIEGO, CA 92121 US
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Contact
Sheila Bruschi
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
MRW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/07/2010
Decision Date
07/15/2010
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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