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FDA 510(k)

Veritas Shoulder System

K-Number: K260556 · 2026-07-01

ApplicantRestor3D
Decision Date2026-07-01
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Veritas Shoulder System is the device name listed in this FDA 510(k) record. The listed applicant is Restor3D. It received FDA 510(k) clearance on 2026-07-01 under 510(k) number K260556. 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 Veritas Shoulder System?

Veritas Shoulder System is a medical device that received FDA 510(k) clearance on 2026-07-01. The listed applicant is Restor3D. The 510(k) number is K260556.

When did Veritas Shoulder System receive FDA 510(k) clearance?

Veritas Shoulder System received FDA 510(k) clearance on 2026-07-01, under 510(k) number K260556.

Who is the listed applicant for Veritas Shoulder System?

The FDA 510(k) record lists Restor3D as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Veritas Shoulder System?

The FDA product code for Veritas 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.

NCT07563803The restor3d Outcomes RegistryNOT_YET_RECRUITING

Other records listing Restor3D 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.

K253992Veritas Reverse Total Shoulder SystemK252067Velora Acetabular SystemK252454Kinos Total Ankle SystemK243643restor3d Reverse Total Shoulder Arthroplasty SystemK243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemK242356TIDAL Fusion Cage System

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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.

K261683Augment 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 OrthopedicsK260583Equinoxe® Shoulder SystemExactech, Inc.

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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