ELEOS™ Limb Salvage System

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

Onkos Surgical

The following data is part of a premarket notification filed by Onkos Surgical with the FDA for Eleos™ Limb Salvage System.

Pre-market Notification Details

• Device ID: K203588
• 510k Number: K203588
• Device Name: ELEOS™ Limb Salvage System
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
• Applicant: Onkos Surgical 77 East Halsey Rd Parsippany, NJ 07054
• Contact: Matthew Vernak
• Correspondent: Matthew Vernak; Onkos Surgical 77 East Halsey Rd Parsippany, NJ 07054
• Product Code: JDI
• Subsequent Product Code: JWH
• Subsequent Product Code: KRO
• Subsequent Product Code: LPH
• Subsequent Product Code: LZO
• CFR Regulation Number: 888.3350 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-12-08
• Decision Date: 2021-02-05