AEQUALIS HUMERAL NAIL SYSTEM

Rod, Fixation, Intramedullary And Accessories

TORNIER

The following data is part of a premarket notification filed by Tornier with the FDA for Aequalis Humeral Nail System.

Pre-market Notification Details

• Device ID: K082754
• 510k Number: K082754
• Device Name: AEQUALIS HUMERAL NAIL SYSTEM
• Classification: Rod, Fixation, Intramedullary And Accessories
• Applicant: TORNIER 100 CAPITAL DRIVE SUITE 201 Warsaw, IN 46582
• Contact: Brian Hodorek
• Correspondent: Brian Hodorek; TORNIER 100 CAPITAL DRIVE SUITE 201 Warsaw, IN 46582
• Product Code: HSB
• CFR Regulation Number: 888.3020 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-09-19
• Decision Date: 2009-01-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00846832088645	K082754	000
00846832090297	K082754	000
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