Apex Femoral 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 Femoral Nailing System.

Pre-market Notification Details

• Device ID: K181375
• 510k Number: K181375
• Device Name: Apex Femoral 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: 2018-05-24
• Decision Date: 2018-07-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05391529588380	K181375	000
05391529588267	K181375	000
05391529588250	K181375	000
05391529588243	K181375	000
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05391529588120	K181375	000
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05391529588397	K181375	000