Veritas Shoulder System— 510(k) K263421

Name: FDA 510(k) clearance K263421
Creator: U.S. Food and Drug Administration
Published: 2026-10-22

Substantially Equivalent

restor3d, inc.

FDA 510(k) clearance K263421 for Veritas Shoulder System, Substantially Equivalent on 2026-10-22. Applicant: restor3d, inc.. Device class: 2.

Clearance details

Applicant: restor3d, inc.
Product code: Product code PHX
Device class: Class 2
Regulation: 21 CFR 888.3660
Advisory panel: Orthopedic
Date received: 2026-09-25
Decision date: 2026-10-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PHX

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K263086 — AltiVate Reverse® Glenosphere with RAVN Technology2026-10-02
K260556 — Veritas Shoulder System2026-07-01
K261683 — Augment Off-Axis Instrument System2026-06-16
K260102 — Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System2026-06-12
K261016 — MSS - Humeral reverse liners extension2026-06-10

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Adverse events under product code PHX

product code PHX

Death: 10
Injury: 9,705
Malfunction: 1,252
Total: 10,967

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.