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FDA 510(k) Application Details - K994308
Device Classification Name
System, Facet Screw Spinal Device
More FDA Info for this Device
510(K) Number
K994308
Device Name
System, Facet Screw Spinal Device
Applicant
NUVASIVE, INC.
10065 OLD GROVE RD.
SAN DIEGO, CA 92131 US
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Contact
STEVE REITZLER
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
12/21/1999
Decision Date
04/18/2000
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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