CoreHip® System

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

Aesculap Implants Systems, LLC

The following data is part of a premarket notification filed by Aesculap Implants Systems, Llc with the FDA for Corehip® System.

Pre-market Notification Details

• Device ID: K172235
• 510k Number: K172235
• Device Name: CoreHip® System
• Classification: Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
• Applicant: Aesculap Implants Systems, LLC 3773 Corporate Parkway Center Valley, PA 18034
• Contact: Paul Amudala
• Correspondent: Paul Amudala; Aesculap Implants Systems, LLC 3773 Corporate Parkway Center Valley, PA 18034
• Product Code: LZO
• Subsequent Product Code: KWY
• Subsequent Product Code: LWJ
• CFR Regulation Number: 888.3353 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-07-25
• Decision Date: 2018-03-28
• Summary: summary