KLS Martin Individual Patient Solutions (IPS) Planning System

Orthopaedic 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 IDK192979
510k NumberK192979
Device Name:KLS Martin Individual Patient Solutions (IPS) Planning System
ClassificationOrthopaedic Surgical Planning And Instrument Guides
Applicant KLS-Martin L.P. 11201 Saint Johns Industrial Parkway S Jacksonville,  FL  32246
ContactJennifer Damato
CorrespondentPam Martin
KLS-Martin L.P. 11201 Saint Johns Industrial Parkway S Jacksonville,  FL  32246
Product CodePBF  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-24
Decision Date2020-03-11

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