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FDA 510(k)

ZCA All-Poly Acetabular Cups

K-Number: K191449 · 2020-07-16

ApplicantZimmer, Inc.
Decision Date2020-07-16
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ZCA All-Poly Acetabular Cups is a medical device manufactured by Zimmer, Inc.. It received FDA 510(k) clearance on 2020-07-16 under approval number K191449. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZCA All-Poly Acetabular Cups?

ZCA All-Poly Acetabular Cups is a medical device that received FDA 510(k) clearance on 2020-07-16. It is manufactured by Zimmer, Inc.. The 510(k) number is K191449.

When was ZCA All-Poly Acetabular Cups approved by the FDA?

ZCA All-Poly Acetabular Cups received FDA 510(k) clearance on 2020-07-16, under approval number K191449.

What company makes ZCA All-Poly Acetabular Cups?

ZCA All-Poly Acetabular Cups is manufactured by Zimmer, Inc..

What is the FDA product code for ZCA All-Poly Acetabular Cups?

The FDA product code for ZCA All-Poly Acetabular Cups is JDI.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.