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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Facet Screw Spinal Device
510(k) Number K230840
Device Name PMT Facet Fixation System, Lumbar (PMT FFS-LX)
Applicant
Providence Medical Technology, Inc.
4234 Hacienda Dr.
Suite 150
Pleasanton,  CA  94588
Applicant Contact Edward Liou
Correspondent
Providence Medical Technology, Inc.
4234 Hacienda Dr.
Suite 150
Pleasanton,  CA  94588
Correspondent Contact Edward Liou
Classification Product Code
MRW  
Date Received03/27/2023
Decision Date 12/19/2023
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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