FDA 510(k)

Catalyst CSR Press-Fit Humeral Components

K-Number: K182500 · 2019-01-11

Decision Date2019-01-11

Product CodeKWT

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Catalyst CSR Press-Fit Humeral Components is the device name listed in this FDA 510(k) record. The listed applicant is Catalyst Orthoscience, Inc.. It received FDA 510(k) clearance on 2019-01-11 under 510(k) number K182500. The device is classified under product code KWT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Catalyst CSR Press-Fit Humeral Components?

Catalyst CSR Press-Fit Humeral Components is a medical device that received FDA 510(k) clearance on 2019-01-11. The listed applicant is Catalyst Orthoscience, Inc.. The 510(k) number is K182500.

When did Catalyst CSR Press-Fit Humeral Components receive FDA 510(k) clearance?

Catalyst CSR Press-Fit Humeral Components received FDA 510(k) clearance on 2019-01-11, under 510(k) number K182500.

Who is the listed applicant for Catalyst CSR Press-Fit Humeral Components?

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

What is the FDA product code for Catalyst CSR Press-Fit Humeral Components?

The FDA product code for Catalyst CSR Press-Fit Humeral Components is KWT.

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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.