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FDA 510(k)

PMT Facet Fixation System, Lumbar (PMT FFS-LX)

K-Number: K230840 · 2023-12-19

ApplicantProvidence Medical Technology, Inc.
Decision Date2023-12-19
Product CodeMRW
DecisionSubstantially Equivalent

Device Summary

PMT Facet Fixation System, Lumbar (PMT FFS-LX) is a medical device manufactured by Providence Medical Technology, Inc.. It received FDA 510(k) clearance on 2023-12-19 under approval number K230840. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PMT Facet Fixation System, Lumbar (PMT FFS-LX)?

PMT Facet Fixation System, Lumbar (PMT FFS-LX) is a medical device that received FDA 510(k) clearance on 2023-12-19. It is manufactured by Providence Medical Technology, Inc.. The 510(k) number is K230840.

When was PMT Facet Fixation System, Lumbar (PMT FFS-LX) approved by the FDA?

PMT Facet Fixation System, Lumbar (PMT FFS-LX) received FDA 510(k) clearance on 2023-12-19, under approval number K230840.

What company makes PMT Facet Fixation System, Lumbar (PMT FFS-LX)?

PMT Facet Fixation System, Lumbar (PMT FFS-LX) is manufactured by Providence Medical Technology, Inc..

What is the FDA product code for PMT Facet Fixation System, Lumbar (PMT FFS-LX)?

The FDA product code for PMT Facet Fixation System, Lumbar (PMT FFS-LX) is MRW.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07277803 Device-Based vs Manual Sensory Training in Low Back Pain NOT_YET_RECRUITING NCT06011551 HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs RECRUITING

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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