KLS Martin Individual Patient Solutions (IPS) Planning System

Cranial Surgical Planning And Instrument Guides

KLS-Martin L.P.

The following data is part of a premarket notification filed by Kls-martin L.p. with the FDA for Kls Martin Individual Patient Solutions (ips) Planning System.

Pre-market Notification Details

Device IDK182889
510k NumberK182889
Device Name:KLS Martin Individual Patient Solutions (IPS) Planning System
ClassificationCranial Surgical Planning And Instrument Guides
Applicant KLS-Martin L.P. 11201 Saint Johns Industrial Parkway S Jacksonville,  FL  32246
ContactJennifer Damato
CorrespondentKatie Rutland
KLS-Martin L.P. 11201 Saint Johns Industrial Parkway S Jacksonville,  FL  32246
Product CodePPT  
CFR Regulation Number882.4310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-10-15
Decision Date2019-07-26
Summary:summary

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