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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 K183589
Device Name PMT Facet Screw
Applicant
Providence Medical Technology, Inc.
3875 Hopyard Rd.
Suite 300
Pleasanton,  CA  94588
Applicant Contact Edward Liou
Correspondent
Providence Medical Technology, Inc.
3875 Hopyard Rd.
Suite 300
Pleasanton,  CA  94588
Correspondent Contact Janie Mandrusov
Classification Product Code
MRW  
Date Received12/21/2018
Decision Date 10/11/2019
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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