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FDA 510(k) Application Details - K230608
Device Classification Name
More FDA Info for this Device
510(K) Number
K230608
Device Name
SPICCA Stand-Alone Cervical Fusion Cages
Applicant
Southern Medical (Pty) Ltd
55 Regency Drive
Route 21 Corporate Park
Irene 0178 ZA
Other 510(k) Applications for this Company
Contact
Dalene Styger
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OVE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/03/2023
Decision Date
08/14/2023
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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