EXCIA

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

AESCULAP, INC.

The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Excia.

Pre-market Notification Details

• Device ID: K061699
• 510k Number: K061699
• Device Name: EXCIA
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented
• Applicant: AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034
• Contact: Lisa M Boyle
• Correspondent: Lisa M Boyle; AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034
• Product Code: LWJ
• Subsequent Product Code: JDI
• Subsequent Product Code: LZO
• CFR Regulation Number: 888.3360 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-06-16
• Decision Date: 2006-08-18
• Summary: summary