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FDA 510(k)

Delta Xtend Reverse Shoulder System

K-Number: K183077 · 2019-05-17

ApplicantDepuy(Ireland)
Decision Date2019-05-17
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Delta Xtend Reverse Shoulder System is the device name listed in this FDA 510(k) record. The listed applicant is Depuy(Ireland). It received FDA 510(k) clearance on 2019-05-17 under 510(k) number K183077. 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 2019-05-17. The listed applicant is Depuy(Ireland). The 510(k) number is K183077.

When did Delta Xtend Reverse Shoulder System receive FDA 510(k) clearance?

Delta Xtend Reverse Shoulder System received FDA 510(k) clearance on 2019-05-17, under 510(k) number K183077.

Who is the listed applicant for Delta Xtend Reverse Shoulder System?

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

What is the FDA product code for Delta Xtend Reverse Shoulder System?

The FDA product code for Delta Xtend Reverse Shoulder System is PHX.

Related Clinical Trials

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.

NCT07464977EMG and Delta Function in Standard RTSA vs LateralizationNOT_YET_RECRUITING

Other records listing Depuy(Ireland) 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.

K212683GLOBAL ICON Stemless Shoulder SystemK192855DELTA XTEND(TM) Reverse Shoulder SystemK190344DePuy Corail AMT Hip ProsthesisK191779Attune Revision LPS InsertsK192448Delta Xtend Revers Shoulder SystemK170806ATTUNE Cemented Tibial Base, Fixed Bearing

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Related Devices (Code: PHX)

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.

K260556Veritas Shoulder SystemRestor3DK261683Augment Off-Axis Instrument SystemZimmer, Inc.K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder SystemStryker Corporation (Tornier, Inc.)K261016MSS - Humeral reverse liners extensionMedacta International, SAK253992Veritas Reverse Total Shoulder SystemRestor3DK252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics

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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