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FDA 510(k) Application Details - K230297
Device Classification Name
System, Facet Screw Spinal Device
More FDA Info for this Device
510(K) Number
K230297
Device Name
System, Facet Screw Spinal Device
Applicant
Providence Medical Technology, Inc
4234 Hacienda Drive, Suite 150
Pleasanton, CA 94588 US
Other 510(k) Applications for this Company
Contact
Edward Liou
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
MRW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/02/2023
Decision Date
08/11/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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