ELEOS™ Bipolar Acetabular System

Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented

Onkos Surgical, Inc.

The following data is part of a premarket notification filed by Onkos Surgical, Inc. with the FDA for Eleos™ Bipolar Acetabular System.

Pre-market Notification Details

• Device ID: K180130
• 510k Number: K180130
• Device Name: ELEOS™ Bipolar Acetabular System
• Classification: Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
• Applicant: Onkos Surgical, Inc. 77 East Halsey Road Parsippany, NJ 07054
• Contact: Jan Triani
• Correspondent: Jan Triani; Onkos Surgical, Inc. 77 East Halsey Road Parsippany, NJ 07054
• Product Code: KWY
• CFR Regulation Number: 888.3390 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-01-17
• Decision Date: 2018-02-23
• Summary: summary