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FDA 510(k)

PMT Facet Screw

K-Number: K183589 · 2019-10-11

ApplicantProvidence Medical Technology, Inc.
Decision Date2019-10-11
Product CodeMRW
DecisionSubstantially Equivalent

Device Summary

PMT Facet Screw is a medical device manufactured by Providence Medical Technology, Inc.. It received FDA 510(k) clearance on 2019-10-11 under approval number K183589. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PMT Facet Screw?

PMT Facet Screw is a medical device that received FDA 510(k) clearance on 2019-10-11. It is manufactured by Providence Medical Technology, Inc.. The 510(k) number is K183589.

When was PMT Facet Screw approved by the FDA?

PMT Facet Screw received FDA 510(k) clearance on 2019-10-11, under approval number K183589.

What company makes PMT Facet Screw?

PMT Facet Screw is manufactured by Providence Medical Technology, Inc..

What is the FDA product code for PMT Facet Screw?

The FDA product code for PMT Facet Screw is MRW.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT06720948 The ION Facet Screw System Ambispective Evaluation ENROLLING_BY_INVITATION

Other Devices by Providence Medical Technology, Inc.

K161642CAVUX™ Cervical Cage K172279PMT Posterior Fixation System K170698ALLY(TM) Bone Screws K163474CAVUX CervicalCage-L SA System K163374ALLY™ Facet Screws K180876DTRAX Spinal System

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Related Devices (Code: MRW)

K161798FacetBRIDGE® SystemLdr Spine USA, Inc. K152137FacetBRIDGE SystemLdr Spine USA K163374ALLY™ Facet ScrewsProvidence Medical Technology, Inc. K180729FaSet Fixation SystemHuvexel Co. , Ltd. K173198Facet Screw Fixation SystemU&I Corporation K192744CORRIDOR Fixation SystemGlobus Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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