Apex Tibial Nailing System

Rod, Fixation, Intramedullary And Accessories

OrthoXel

The following data is part of a premarket notification filed by Orthoxel with the FDA for Apex Tibial Nailing System.

Pre-market Notification Details

• Device ID: K170972
• 510k Number: K170972
• Device Name: Apex Tibial Nailing System
• Classification: Rod, Fixation, Intramedullary And Accessories
• Applicant: OrthoXel Rubicon Center Cork Institute Of Technology, Bishopstown Bishopstown, IE T12 Y275
• Contact: Aisling O'sullivan
• Correspondent: Hollace Saas Rhodes; Musculoskeletal Clinical Regulatory Advisers LLC 1050 K Street NW Suite 1000 Washington, DC 20001
• Product Code: HSB
• CFR Regulation Number: 888.3020 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-04-03
• Decision Date: 2017-12-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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