Medical Device Manufacturer · US , Jacksonville , FL

KLS-Martin L.P. - FDA 510(k) Cleared Devices

79 submissions · 79 cleared · Since 1994

Recent clearances: KLS Martin IPS Oral-Max Implants - MR Conditional, KLS Martin Pure Pectus System, KLS Martin Ixos System

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79

Total

79

Cleared

0

Denied

FDA 510(k) Regulatory Record - KLS-Martin L.P. Neurology ✕

13 devices

1-12 of 13

Cleared Nov 10, 2025

KLS Martin Cranial Implants - MR Conditional

Neurology · 88d

Cleared Nov 21, 2023

Neurology · 299d

Cleared Jun 03, 2022

KLS Martin Neuro Rongeurs

Neurology · 448d

Cleared Aug 31, 2020

KLS Martin Individual Patient Solutions (IPS) Planning System

Neurology · 132d

Cleared Jul 26, 2019

KLS Martin Individual Patient Solutions (IPS) Planning System

Neurology · 284d

Cleared May 05, 2017

Internal Distraction - Sterile

Neurology · 163d

Cleared Nov 09, 2015

Patient Contoured Implant-PEEK (PCI-PEEK)

Neurology · 171d

Cleared Aug 27, 2015

RxG Distraction System

Neurology · 156d

Cleared Jan 17, 2013

Neurology · 230d

Cleared Dec 19, 2007

PATIENT CONTOURED MESH-PEEK (PCM-P)

Neurology · 85d

Cleared Nov 22, 2006

KLS MARTIN QUICK DISC

Neurology · 58d

Cleared Oct 31, 2006

PATIENT CONTOURED MESH (PCM)

Neurology · 61d