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FDA 510(k) Application Details - K251885
Device Classification Name
System, Facet Screw Spinal Device
More FDA Info for this Device
510(K) Number
K251885
Device Name
System, Facet Screw Spinal Device
Applicant
Providence Medical Technology, Inc.
4234 Hacienda Dr Ste 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
06/20/2025
Decision Date
07/10/2025
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K251885
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