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FDA 510(k) Application Details - K201585
Device Classification Name
More FDA Info for this Device
510(K) Number
K201585
Device Name
Monterey AL Interbody System
Applicant
Stryker Corporation
2 Pearl Court
Allendale, NJ 07401 US
Other 510(k) Applications for this Company
Contact
Alexia Haralambous
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OVD
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More FDA Info for this Product Code
Date Received
06/11/2020
Decision Date
08/10/2020
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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