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FDA 510(k)

Global Shoulder and Delta CTA systems

K-Number: K203230 · 2021-04-02

ApplicantDepuy Lnc.
Decision Date2021-04-02
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Global Shoulder and Delta CTA systems is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Lnc.. It received FDA 510(k) clearance on 2021-04-02 under 510(k) number K203230. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Global Shoulder and Delta CTA systems?

Global Shoulder and Delta CTA systems is a medical device that received FDA 510(k) clearance on 2021-04-02. The listed applicant is Depuy Lnc.. The 510(k) number is K203230.

When did Global Shoulder and Delta CTA systems receive FDA 510(k) clearance?

Global Shoulder and Delta CTA systems received FDA 510(k) clearance on 2021-04-02, under 510(k) number K203230.

Who is the listed applicant for Global Shoulder and Delta CTA systems?

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

What is the FDA product code for Global Shoulder and Delta CTA systems?

The FDA product code for Global Shoulder and Delta CTA systems is KWS.

Related Devices (Code: KWS)

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.

K260721Tornier Perform Advanced GlenoidTornier, Inc.K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)Stryker Corporation (Tornier, Inc.)

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.

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