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FDA 510(k) Application Details - K214047
Device Classification Name
More FDA Info for this Device
510(K) Number
K214047
Device Name
EL CAPITAN Anterior Lumbar Interbody Fusion System
Applicant
Astura Medical
4949 W Royal Ln.
Irving, TX 75063 US
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Contact
Parker Kelch
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Regulation Number
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Classification Product Code
OVD
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Date Received
12/27/2021
Decision Date
03/30/2022
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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