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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 a medical device manufactured by Depuy Lnc.. It received FDA 510(k) clearance on 2021-04-02 under approval 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. It is manufactured by Depuy Lnc.. The 510(k) number is K203230.

When was Global Shoulder and Delta CTA systems approved by the FDA?

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

What company makes Global Shoulder and Delta CTA systems?

Global Shoulder and Delta CTA systems is manufactured by Depuy Lnc..

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.

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Related PubMed Literature

PMID: 41967377 Governing the rise of AI in healthcare: A comparative governance document and implementation implications across five jurisdictions. Social science & medicine (1982) (2026) PMID: 41844911 Toward global standards for SaMD: introducing a proposal for Good Digital Medicine Practices (GDMP). NPJ digital medicine (2026) PMID: 41694722 Lessons from global materiovigilance systems: What India can learn? Perspectives in clinical research (2026) PMID: 41407822 Do we need prequalification of AI as a medical device to drive equitable adoption. NPJ digital medicine (2025)

Related Devices (Code: KWS)

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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.

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