FDA 510(k)

Exeter® X3® RimFit® Cup

K-Number: K213701 · 2022-02-01

ApplicantHowmedica Osteonics Corp., Dba Stryker Orthopaedics

Decision Date2022-02-01

Product CodeJDI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Exeter® X3® RimFit® Cup is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. It received FDA 510(k) clearance on 2022-02-01 under 510(k) number K213701. 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 Exeter® X3® RimFit® Cup?

Exeter® X3® RimFit® Cup is a medical device that received FDA 510(k) clearance on 2022-02-01. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The 510(k) number is K213701.

When did Exeter® X3® RimFit® Cup receive FDA 510(k) clearance?

Exeter® X3® RimFit® Cup received FDA 510(k) clearance on 2022-02-01, under 510(k) number K213701.

Who is the listed applicant for Exeter® X3® RimFit® Cup?

The FDA 510(k) record lists Howmedica Osteonics Corp., Dba Stryker Orthopaedics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Exeter® X3® RimFit® Cup?

The FDA product code for Exeter® X3® RimFit® Cup is JDI.

Other records listing Howmedica Osteonics Corp., Dba Stryker Orthopaedics as applicant

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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.