LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL BODIES,

Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented

LIMA-LTO S.P.A.

The following data is part of a premarket notification filed by Lima-lto S.p.a. with the FDA for Lima-lio Smr Shoulder System - Humeral Stems, Lima-lio Smr Shoulder System - Humeral Bodies,.

Pre-market Notification Details

Device IDK100858
510k NumberK100858
Device Name:LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL BODIES,
ClassificationProsthesis, Shoulder, Non-constrained, Metal/polymer Cemented
Applicant LIMA-LTO S.P.A. PO BOX 696 Winona Lake,  IN  46590
ContactCheryl Hastings
CorrespondentCheryl Hastings
LIMA-LTO S.P.A. PO BOX 696 Winona Lake,  IN  46590
Product CodeKWT  
CFR Regulation Number888.3650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-03-26
Decision Date2010-12-10
Summary:summary

NIH GUDID Devices

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