FDA 510(k)

Dall-Miles® Cable System

K-Number: K202016 · 2020-10-16

ApplicantHowmedica Osteonics Corp., Dba Stryker Orthopaedics

Decision Date2020-10-16

Product CodeJDQ

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Dall-Miles® Cable System 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 2020-10-16 under 510(k) number K202016. The device is classified under product code JDQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dall-Miles® Cable System?

Dall-Miles® Cable System is a medical device that received FDA 510(k) clearance on 2020-10-16. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The 510(k) number is K202016.

When did Dall-Miles® Cable System receive FDA 510(k) clearance?

Dall-Miles® Cable System received FDA 510(k) clearance on 2020-10-16, under 510(k) number K202016.

Who is the listed applicant for Dall-Miles® Cable System?

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 Dall-Miles® Cable System?

The FDA product code for Dall-Miles® Cable System is JDQ.

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

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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.