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FDA 510(k) Application Details - K200066
Device Classification Name
More FDA Info for this Device
510(K) Number
K200066
Device Name
Posterior Fusion Plate, HA Posterior Fusion Plate
Applicant
Spinal Simplicity LLC
6600 College Blvd, Ste 220
Overland Park, KS 66211 US
Other 510(k) Applications for this Company
Contact
Adam Rogers
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Regulation Number
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Classification Product Code
PEK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/13/2020
Decision Date
12/10/2020
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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