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FDA 510(k) Application Details - K130445
Device Classification Name
More FDA Info for this Device
510(K) Number
K130445
Device Name
VAULT ALIF SYSTEM
Applicant
SPINAL USA
1001 OAKWOOD BLVD
ROUND ROCK, TX 78681 US
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Contact
J.D. WEBB
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Regulation Number
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Classification Product Code
OVD
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Date Received
02/21/2013
Decision Date
04/25/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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