AEQUALIS REVERSED SHOULDER PROSTHESIS— 510(k) K030941

Name: FDA 510(k) clearance K030941
Creator: U.S. Food and Drug Administration
Published: 2004-05-14

Substantially Equivalent

Tornier

FDA 510(k) clearance K030941 for AEQUALIS REVERSED SHOULDER PROSTHESIS, Substantially Equivalent on 2004-05-14. Applicant: Tornier. Device class: 2.

Clearance details

Applicant: Tornier
Product code: Code PHX
Device class: Class 2
Regulation: 21 CFR 888.3660
Advisory panel: Orthopedic
Date received: 2003-03-25
Decision date: 2004-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Midvale, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PHX

view all

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
K253992 — Veritas Reverse Total Shoulder System2026-05-07

More clearances from Tornier

view all

K112144 — AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROSTHESIS2012-03-13
K111970 — KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT2012-02-23
K111902 — AEQUALIS SHOULDER SYSTEM2011-11-03
K094013 — HLS KNEETEC SYSTEM2011-05-05
K100142 — AEQUALIS REVERSED SHOULDER PROSTHESIS2010-05-06

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.