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FDA 510(k) Application Details - K200523
Device Classification Name
Appliance, Fixation, Spinal Intervertebral Body
More FDA Info for this Device
510(K) Number
K200523
Device Name
Appliance, Fixation, Spinal Intervertebral Body
Applicant
Elite Surgical Supplies (PTY) LTD
54 De Havilland Cresent, Persequor Technopark
Pretoria 0020 ZA
Other 510(k) Applications for this Company
Contact
Thanos Spirakis
Other 510(k) Applications for this Contact
Regulation Number
888.3060
More FDA Info for this Regulation Number
Classification Product Code
KWQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/02/2020
Decision Date
04/30/2020
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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