FDA 510(k)

DELTA XTEND Reverse Shoulder System

K-Number: K203694 · 2021-07-22

Decision Date2021-07-22

Product CodePHX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

DELTA XTEND Reverse Shoulder System is a medical device manufactured by Depuy Ireland UC. It received FDA 510(k) clearance on 2021-07-22 under approval number K203694. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DELTA XTEND Reverse Shoulder System?

DELTA XTEND Reverse Shoulder System is a medical device that received FDA 510(k) clearance on 2021-07-22. It is manufactured by Depuy Ireland UC. The 510(k) number is K203694.

When was DELTA XTEND Reverse Shoulder System approved by the FDA?

DELTA XTEND Reverse Shoulder System received FDA 510(k) clearance on 2021-07-22, under approval number K203694.

What company makes DELTA XTEND Reverse Shoulder System?

DELTA XTEND Reverse Shoulder System is manufactured by Depuy Ireland UC.

What is the FDA product code for DELTA XTEND Reverse Shoulder System?

The FDA product code for DELTA XTEND Reverse Shoulder System is PHX.

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Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026)

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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.