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FDA 510(k)

DELTA XTEND Reverse Shoulder System

K-Number: K210167 · 2021-02-19

ApplicantDePuy Orthopaedics, Inc.
Decision Date2021-02-19
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 Orthopaedics, Inc.. It received FDA 510(k) clearance on 2021-02-19 under 510(k) number K210167. 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 2021-02-19. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K210167.

When did DELTA XTEND Reverse Shoulder System receive FDA 510(k) clearance?

DELTA XTEND Reverse Shoulder System received FDA 510(k) clearance on 2021-02-19, under 510(k) number K210167.

Who is the listed applicant for DELTA XTEND Reverse Shoulder System?

The FDA 510(k) record lists DePuy Orthopaedics, Inc. 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.

NCT06323980INHANCE Stemless Reverse Shoulder IDERECRUITINGNCT0283985014022 ATTUNE Cementless RP Clinical Performance EvaluationACTIVE_NOT_RECRUITINGNCT03153449ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty PopulationACTIVE_NOT_RECRUITINGNCT03153475ATTUNE Revision System in the Revision Total Knee Arthroplasty PopulationACTIVE_NOT_RECRUITINGNCT06631638EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN))RECRUITINGNCT07464977EMG and Delta Function in Standard RTSA vs LateralizationNOT_YET_RECRUITING

Other records listing DePuy Orthopaedics, Inc. 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.

PMA P070026Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncementedK252887DePuy ATTUNE™ Knee SystemK231503CUPTIMIZE™ AdvancedK213839DePuy Corail AMT Hip ProsthesisK203167DePuy Corail AMT Hip ProsthesisK202472ACTIS Duofix Hip Prosthesis

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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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