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 ID: K100858
• 510k Number: K100858
• Device Name: LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL BODIES,
• Classification: Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented
• Applicant: LIMA-LTO S.P.A. PO BOX 696 Winona Lake, IN 46590
• Contact: Cheryl Hastings
• Correspondent: Cheryl Hastings; LIMA-LTO S.P.A. PO BOX 696 Winona Lake, IN 46590
• Product Code: KWT
• CFR Regulation Number: 888.3650 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-03-26
• Decision Date: 2010-12-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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