ZCA All-Poly Acetabular Cups

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

Zimmer, Inc.

The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zca All-poly Acetabular Cups.

Pre-market Notification Details

• Device ID: K191449
• 510k Number: K191449
• Device Name: ZCA All-Poly Acetabular Cups
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
• Applicant: Zimmer, Inc. 1800 W. Center Street Warsaw, IN 46580
• Contact: Caleb Barylski
• Correspondent: Caleb Barylski; Zimmer, Inc. 1800 W. Center Street Warsaw, IN 46580
• Product Code: JDI
• CFR Regulation Number: 888.3350 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-05-31
• Decision Date: 2020-07-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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