Talon DistalFix Humeral Nail

Rod, Fixation, Intramedullary And Accessories

Orthopedic Designs North America, Inc.

The following data is part of a premarket notification filed by Orthopedic Designs North America, Inc. with the FDA for Talon Distalfix Humeral Nail.

Pre-market Notification Details

• Device ID: K173255
• 510k Number: K173255
• Device Name: Talon DistalFix Humeral Nail
• Classification: Rod, Fixation, Intramedullary And Accessories
• Applicant: Orthopedic Designs North America, Inc. 5912 Breckenridge Parkway Suite F Tampa, FL 33610
• Contact: Robin Wilson
• Correspondent: Robin Wilson; Orthopedic Designs North America, Inc. 5912 Breckenridge Parkway Suite F Tampa, FL 33610
• Product Code: HSB
• CFR Regulation Number: 888.3020 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-10-10
• Decision Date: 2018-02-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B058HTN10C011	K173255	000
B058HTN4083001	K173255	000
B058HTN4083151	K173255	000
B058HTN4091651	K173255	000
B058HTN4091801	K173255	000
B058HTN4091951	K173255	000
B058HTN4092101	K173255	000
B058HTN4092251	K173255	000
B058HTN4092401	K173255	000
B058HTN4092551	K173255	000
B058HTN4092701	K173255	000
B058HTN4092851	K173255	000
B058HTN4093001	K173255	000
B058HTN4093151	K173255	000
B058HTN4082851	K173255	000
B058HTN4082701	K173255	000
B058HTN4082551	K173255	000
B058HTN10C01L1	K173255	000
B058HTN10C051	K173255	000
B058HTN10C05L1	K173255	000
B058HTN10C101	K173255	000
B058HTN10C10L1	K173255	000
B058HTN10C151	K173255	000
B058HTN10C15L1	K173255	000
B058HTN4081651	K173255	000
B058HTN4081801	K173255	000
B058HTN4081951	K173255	000
B058HTN4082101	K173255	000
B058HTN4082251	K173255	000
B058HTN4082401	K173255	000
B058HTN4101651	K173255	000
B058HTN4101801	K173255	000
B058HTN4101951	K173255	000
B058HTNU4341	K173255	000
B058HTNU4361	K173255	000
B058HTNU4381	K173255	000
B058HTNU4401	K173255	000
B058HTNU4421	K173255	000
B058HTNU4441	K173255	000
B058HTNU4461	K173255	000
B058HTNU4481	K173255	000
B058HTNU4501	K173255	000
B058HTNU4521	K173255	000
B058HTNU4541	K173255	000
B058HTNU4561	K173255	000
B058HTNU4581	K173255	000
B058HTNU4321	K173255	000
B058HTNU4301	K173255	000
B058HTNU4281	K173255	000
B058HTN4102101	K173255	000
B058HTN4102251	K173255	000
B058HTN4102401	K173255	000
B058HTN4102551	K173255	000
B058HTN4102701	K173255	000
B058HTN4102851	K173255	000
B058HTN4103001	K173255	000
B058HTN4103151	K173255	000
B058HTNU4181	K173255	000
B058HTNU4201	K173255	000
B058HTNU4221	K173255	000
B058HTNU4241	K173255	000
B058HTNU4261	K173255	000
B058HTNU4601	K173255	000