The Simple Locking IntraMedullary (SLIM) System

Rod, Fixation, Intramedullary And Accessories

PEGA MEDICAL INC.

The following data is part of a premarket notification filed by Pega Medical Inc. with the FDA for The Simple Locking Intramedullary (slim) System.

Pre-market Notification Details

• Device ID: K143355
• 510k Number: K143355
• Device Name: The Simple Locking IntraMedullary (SLIM) System
• Classification: Rod, Fixation, Intramedullary And Accessories
• Applicant: PEGA MEDICAL INC. 1111 AUTOROUTE CHOMEDEY Laval, CA H7w 5j8
• Contact: Ariel R Dujovne
• Correspondent: Ariel R Dujovne; PEGA MEDICAL INC. 1111 AUTOROUTE CHOMEDEY Laval, CA H7w 5j8
• Product Code: HSB
• CFR Regulation Number: 888.3020 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-11-24
• Decision Date: 2015-07-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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