MPACT EXTENSION

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

MEDACTA INTERNATIONAL

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

Pre-market Notification Details

• Device ID: K122641
• 510k Number: K122641
• Device Name: MPACT EXTENSION
• Classification: Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
• Applicant: MEDACTA INTERNATIONAL 4725 Calle Quetzal, Unit B Camarillo, CA 93012
• Contact: Adam Gross
• Correspondent: Adam Gross; MEDACTA INTERNATIONAL 4725 Calle Quetzal, Unit B Camarillo, CA 93012
• Product Code: LZO
• CFR Regulation Number: 888.3353 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-08-29
• Decision Date: 2012-09-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07630030810121	K122641	000
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