Cleared Traditional

KLS Martin Individual Patient Solutions (IPS) Planning System

K201052 · KLS-Martin L.P. · Neurology

Aug 2020

Decision

132d

Days

Class 2

Risk

About This 510(k) Submission

K201052 is an FDA 510(k) clearance for the KLS Martin Individual Patient Solutions (IPS) Planning System, a Cranial Surgical Planning And Instrument Guides (Class II — Special Controls, product code PPT), submitted by KLS-Martin L.P. (Jacksonville, US). The FDA issued a Cleared decision on August 31, 2020, 132 days after receiving the submission on April 21, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4310.

Submission Details

510(k) Number	K201052 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 21, 2020
Decision Date	August 31, 2020
Days to Decision	132 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	PPT — Cranial Surgical Planning And Instrument Guides
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.4310
Definition	Software And Hardware For Surgical Planning To Create Patient-specific Anatomical Models, Surgical Templates, And Guides For Use In The Marking Or Cutting Of Cranial Bone For Neurosurgical Procedures.