Mpact® 3D Metal Implants - DMLS Technology

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

Medacta International SA

The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Mpact® 3d Metal Implants - Dmls Technology.

Pre-market Notification Details

• Device ID: K202568
• 510k Number: K202568
• Device Name: Mpact® 3D Metal Implants - DMLS Technology
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: Medacta International SA Strada Regina Castel San Pietro, CH Ch-6874
• Contact: Stefano Baj
• Correspondent: Chris Lussier; Medacta USA 3973 Delp Street Memphis, TN 38118
• Product Code: LPH
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-09-04
• Decision Date: 2021-12-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07630971212626	K202568	000
07630040723275	K202568	000
07630040723282	K202568	000
07630040723299	K202568	000
07630040723305	K202568	000
07630040723312	K202568	000
07630040723329	K202568	000
07630040723336	K202568	000
07630040723343	K202568	000
07630040723350	K202568	000
07630040723367	K202568	000
07630971212565	K202568	000
07630971212572	K202568	000
07630971212589	K202568	000
07630971212596	K202568	000
07630971212602	K202568	000
07630971212619	K202568	000
07630040723268	K202568	000