UNIVATION

Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer

AESCULAP IMPLANT SYSTEMS, LLC

The following data is part of a premarket notification filed by Aesculap Implant Systems, Llc with the FDA for Univation.

Pre-market Notification Details

• Device ID: K131167
• 510k Number: K131167
• Device Name: UNIVATION
• Classification: Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
• Applicant: AESCULAP IMPLANT SYSTEMS, LLC 3773 Corporate Parkway Center Valley, PA 18034
• Contact: Julie T Wing
• Correspondent: Julie T Wing; AESCULAP IMPLANT SYSTEMS, LLC 3773 Corporate Parkway Center Valley, PA 18034
• Product Code: HRY
• CFR Regulation Number: 888.3530 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-04-24
• Decision Date: 2013-10-17
• Summary: summary