Veritas Shoulder System— 510(k) K260556
Substantially EquivalentRestor3D
FDA 510(k) clearance K260556 for Veritas Shoulder System, Substantially Equivalent on 2026-07-01. Applicant: Restor3D. Device class: 2.
Clearance details
- Applicant
- Restor3D
- Product code
- Code PHX
- Device class
- Class 2
- Regulation
- 21 CFR 888.3660
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Durham, NC, US
Recent devices under product code PHX
view all- K261683 — Augment Off-Axis Instrument System
- K260102 — Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System
- K261016 — MSS - Humeral reverse liners extension
- K253992 — Veritas Reverse Total Shoulder System
- K252404 — Comprehensive Reverse Shoulder - HA Glenosphere Baseplates
More clearances from Restor3D
view allAdverse events under product code PHX
product code PHX- Death
- 10
- Injury
- 9,705
- Malfunction
- 1,252
- Total
- 10,967
Source: openFDA MAUDE database, through . 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.