Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

KLS Martin Individual Patient Solutions

K-Number: K163579 · 2017-11-21

ApplicantKLS Martin L.P.
Decision Date2017-11-21
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KLS Martin Individual Patient Solutions is a medical device manufactured by KLS Martin L.P.. It received FDA 510(k) clearance on 2017-11-21 under approval number K163579. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KLS Martin Individual Patient Solutions?

KLS Martin Individual Patient Solutions is a medical device that received FDA 510(k) clearance on 2017-11-21. It is manufactured by KLS Martin L.P.. The 510(k) number is K163579.

When was KLS Martin Individual Patient Solutions approved by the FDA?

KLS Martin Individual Patient Solutions received FDA 510(k) clearance on 2017-11-21, under approval number K163579.

What company makes KLS Martin Individual Patient Solutions?

KLS Martin Individual Patient Solutions is manufactured by KLS Martin L.P..

What is the FDA product code for KLS Martin Individual Patient Solutions?

The FDA product code for KLS Martin Individual Patient Solutions is JEY.

Related Clinical Trials

NCT07607366 Effects of Negative Pressure Wound Bandaging After Mastectomy RECRUITING NCT07599124 Effectiveness of Light Therapy Across Seasons COMPLETED NCT06945731 The Effectiveness of Repetitive Transcranial Magnetic Stimulation for Weight Loss in Overweight and Obese Patients COMPLETED NCT07590349 Personalized Robotic Telerehabilitation for Upper Limb Functional Recovery After Stroke in a Home-Based Setting NOT_YET_RECRUITING NCT07582809 Clinical Investigation to Observe the Long-term Safety and Efficacy of the Digital Medical Device 'BELL-001' in Patients Diagnosed With Insomnia NOT_YET_RECRUITING NCT03795675 CI Following VS Removal or Labyrinthectomy ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 41813232 Artificial Intelligence Applications in Medical Devices for Personalized Health Care Solutions: Systematic Review. Journal of medical Internet research (2026) PMID: 41596046 A Review of 3D-Printed Medical Devices for Cancer Radiation Therapy. Bioengineering (Basel, Switzerland) (2026) PMID: 41543941 Opportunities and Challenges in Precision Neurotherapeutics. Annual review of biomedical engineering (2026) PMID: 40976520 Reusing clinical trial data to consolidate and advance medical knowledge. Journal of clinical epidemiology (2025)

Other Devices by KLS Martin L.P.

K161259KLS Martin Cannulated Headless Screws K161470Internal Distraction - Sterile K151983KLS Martin LSS Plating System K163315Internal Distraction - Sterile K170124Level One Hand Plating System K173320KLS Martin L1 MMF System

View all 11 devices →

Related Devices (Code: JEY)

K160363OPTIMUS CMF SYSTEMOsteonic Co., Ltd. K170773Stryker Universal MeshStryker K172572Stryker Upper-Face AXS screws and Mid-Face AXS screwsStryker K170272TruMatch CMF Titanium 3D Printed Implant SystemMaterialise NV K171364MP LeFort I PlatesStryker K180204CranioMaxillofacial Fixation (CMF) System - CMF VisionareVisionare, LLC

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.

↑