Mpact® 3D Metal™ Implants And Augments 3D Metal™

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 And Augments 3d Metal™.

Pre-market Notification Details

• Device ID: K171966
• 510k Number: K171966
• Device Name: Mpact® 3D Metal™ Implants And Augments 3D Metal™
• 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: Elizabeth Rose; Mapi USA, Inc. 2343 Alexandria Dirve Suite 100 Lexington, KY 40504
• Product Code: LPH
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-06-30
• Decision Date: 2018-03-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07630030812569	K171966	000
07630030888984	K171966	000
07630030888991	K171966	000
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07630030885471	K171966	000
07630030812668	K171966	000
07630030812651	K171966	000
07630030812576	K171966	000
07630030812583	K171966	000
07630030812590	K171966	000
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07630030812613	K171966	000
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07630030812644	K171966	000
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07630030889080	K171966	000
07630040707947	K171966	000
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07630040707985	K171966	000
07630040707992	K171966	000
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07630040707930	K171966	000
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07630030889158	K171966	000
07630040707909	K171966	000
07630040708029	K171966	000