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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 the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2020-07-16 under 510(k) 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. The listed applicant is Zimmer, Inc.. The 510(k) number is K191449.

When did ZCA All-Poly Acetabular Cups receive FDA 510(k) clearance?

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

Who is the listed applicant for ZCA All-Poly Acetabular Cups?

The FDA 510(k) record lists Zimmer, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

View on FDA Database →

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

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