Cleared Traditional

KLS Martin Individual Patient Solutions (IPS) Planning System

K182889 · KLS-Martin L.P. · Neurology

Jul 2019

Decision

284d

Days

Class 2

Risk

About This 510(k) Submission

K182889 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 July 26, 2019, 284 days after receiving the submission on October 15, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4310.

Submission Details

510(k) Number	K182889 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 15, 2018
Decision Date	July 26, 2019
Days to Decision	284 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.