Medacta Anatomic Shoulder Prosthesis

Prosthesis, Shoulder, 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 Anatomic Shoulder Prosthesis.

Pre-market Notification Details

• Device ID: K170910
• 510k Number: K170910
• Device Name: Medacta Anatomic Shoulder Prosthesis
• Classification: Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
• Applicant: Medacta International SA Strada Regina Castel San Pietro, CH Ch-6874
• Contact: Stefano Baj
• Correspondent: Roshana Ahmed, M.a., Rac; Mapi USA, Inc. 2343 Alexandria Drive Suite 100 Lexington, KY 40504
• Product Code: KWS
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-03-28
• Decision Date: 2017-08-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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