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FDA 510(k) Application Details - K180502
Device Classification Name
More FDA Info for this Device
510(K) Number
K180502
Device Name
S128 Anterior Lumbar Interbody Fusion (ALIF) System
Applicant
Renovis Surgical Technologies Inc.
1901 W. Lugonia Ave., Ste 340
Redlands, CA 92374 US
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Contact
Anthony DeBenedictis
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Regulation Number
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Classification Product Code
OVD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/26/2018
Decision Date
06/14/2018
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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