FDA 510(k)

Catalyst CSR 3 Peg Glenoids

K-Number: K173812 · 2018-03-09

Decision Date2018-03-09

Product CodeKWT

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Catalyst CSR 3 Peg Glenoids 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 2018-03-09 under 510(k) number K173812. 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 3 Peg Glenoids?

Catalyst CSR 3 Peg Glenoids is a medical device that received FDA 510(k) clearance on 2018-03-09. The listed applicant is Catalyst Orthoscience, Inc.. The 510(k) number is K173812.

When did Catalyst CSR 3 Peg Glenoids receive FDA 510(k) clearance?

Catalyst CSR 3 Peg Glenoids received FDA 510(k) clearance on 2018-03-09, under 510(k) number K173812.

Who is the listed applicant for Catalyst CSR 3 Peg Glenoids?

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 3 Peg Glenoids?

The FDA product code for Catalyst CSR 3 Peg Glenoids is KWT.

Other records listing Catalyst Orthoscience, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.