MPACT ACETABULAR SYSTEM

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

MEDACTA INTERNATIONAL

The following data is part of a premarket notification filed by Medacta International with the FDA for Mpact Acetabular System.

Pre-market Notification Details

• Device ID: K103721
• 510k Number: K103721
• Device Name: MPACT ACETABULAR SYSTEM
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: MEDACTA INTERNATIONAL 13721 VIA TRES VISTA San Diego, CA 92129
• Contact: Natalie J Kennel
• Correspondent: Natalie J Kennel; MEDACTA INTERNATIONAL 13721 VIA TRES VISTA San Diego, CA 92129
• Product Code: LPH
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-12-21
• Decision Date: 2011-03-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07630030811531	K103721	000
07630030811302	K103721	000
07630030811296	K103721	000
07630030811289	K103721	000
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