Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Delta Xtend Revers Shoulder System

K-Number: K192448 · 2019-10-04

ApplicantDepuy(Ireland)
Decision Date2019-10-04
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Delta Xtend Revers 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 2019-10-04 under 510(k) number K192448. 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 Revers Shoulder System?

Delta Xtend Revers Shoulder System is a medical device that received FDA 510(k) clearance on 2019-10-04. The listed applicant is Depuy(Ireland). The 510(k) number is K192448.

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

Delta Xtend Revers Shoulder System received FDA 510(k) clearance on 2019-10-04, under 510(k) number K192448.

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

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

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 InsertsK183077Delta Xtend Reverse Shoulder SystemK170806ATTUNE Cemented Tibial Base, Fixed Bearing

View all 9 devices →

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.

↑