PMT Facet Screw

FDA 510(k) K183589 · Providence Medical Technology, Inc.

Substantially Equivalent

510(k) numberK183589

Submission

Device name
PMT Facet Screw
Applicant
Providence Medical Technology, Inc.
Pleasanton, CA, US
Received
December 21, 2018
Decision date
October 11, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MRW – System, Facet Screw Spinal Device
Device class
Unclassified
Implant
Yes

Other 510(k)s with product code MRW

510(k)DeviceApplicantDecision
K261209Ion-LMRW · Traditional SurGenTec, LLC06/11/2026SE
K253676CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)MRW · Traditional Providence Medical Technology, Inc.05/14/2026SE
K253432DiversiVy™ Facet Screw SystemMRW · Traditional Vy Spine, LLC03/19/2026SE
K251714Ion-CMRW · Traditional SurGenTec, LLC01/16/2026SE
K250679FFX Facet Fixation SystemMRW · Traditional Sc Medica12/04/2025SE
K253190CORUS-LX ImplantMRW · Traditional Providence Medical Technology, Inc.11/20/2025SE
K252153FFX Facet Fixation SystemMRW · Traditional Sc Medica10/16/2025SE
K251885CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX ImplantMRW · Special Providence Medical Technology, Inc.07/10/2025SE
K250920Arthrex Spine Compression FT ScrewMRW · Traditional Arthrex, Inc.05/22/2025SE
K242527The Karma® Fixation SystemMRW · Traditional Spinal Elements, Inc.05/21/2025SE

More from Spinal Elements, Inc.

510(k)DeviceDecision
K261665CORUS™ Navigation System-GNOLO · Special 06/18/2026SE
K253676CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)MRW · Traditional 05/14/2026SE
K253190CORUS-LX ImplantMRW · Traditional 11/20/2025SE
K251060CORUS™ Navigation System-GXOLO · Traditional 07/30/2025SE
K251885CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX ImplantMRW · Special 07/10/2025SE
K241035PMT Posterior Cervical Stabilization System (PCSS)MRW · Traditional 06/25/2024SE
K240625CORUS Navigation Access SystemOLO · Traditional 05/03/2024SE
K230840PMT Facet Fixation System, Lumbar (PMT FFS-LX)MRW · Traditional 12/19/2023SE
K230297PMT Expandable Cage (PMT EXP)MRW · Traditional 08/11/2023SE
K220951PMT Facet Fixation System (PMT FFS)MRW · Traditional 12/09/2022SE

Questions and answers

When was PMT Facet Screw cleared by the FDA?

PMT Facet Screw (K183589) received a 510(k) decision of Substantially Equivalent on October 11, 2019, 294 days after the submission was received.

What is the product code of K183589?

The FDA product code is MRW – System, Facet Screw Spinal Device, a Unclassified device.