MEDACTA TOTAL HIP PROSTHESIS SYSTEM - LINE EXTENSION

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

MEDACTA INTERNATIONAL, SA

The following data is part of a premarket notification filed by Medacta International, Sa with the FDA for Medacta Total Hip Prosthesis System - Line Extension.

Pre-market Notification Details

• Device ID: K080885
• 510k Number: K080885
• Device Name: MEDACTA TOTAL HIP PROSTHESIS SYSTEM - LINE EXTENSION
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
• Applicant: MEDACTA INTERNATIONAL, SA 13721 VIA TRES VISTA San Diego, CA 92129
• Contact: Natalie J Kennel
• Correspondent: Natalie J Kennel; MEDACTA INTERNATIONAL, SA 13721 VIA TRES VISTA San Diego, CA 92129
• Product Code: JDI
• CFR Regulation Number: 888.3350 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-03-31
• Decision Date: 2008-04-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07630030805486	K080885	000
07630030805479	K080885	000
07630030805240	K080885	000
07630030805233	K080885	000
07630030805226	K080885	000
07630030805219	K080885	000
07630030805202	K080885	000