HLS UNI EVOLUTION PROSTHESIS— 510(k) K022211

Name: FDA 510(k) clearance K022211
Creator: U.S. Food and Drug Administration
Published: 2003-05-22

Substantially Equivalent

Tornier

FDA 510(k) clearance K022211 for HLS UNI EVOLUTION PROSTHESIS, Substantially Equivalent on 2003-05-22. Applicant: Tornier. Device class: 2.

Clearance details

Applicant: Tornier
Product code: Code HSX
Device class: Class 2
Regulation: 21 CFR 888.3520
Advisory panel: Orthopedic
Date received: 2002-07-08
Decision date: 2003-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montbonnot, FR

Download summary PDF View on FDA.gov ↗

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K112144 — AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROSTHESIS2012-03-13
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K111902 — AEQUALIS SHOULDER SYSTEM2011-11-03
K094013 — HLS KNEETEC SYSTEM2011-05-05
K100142 — AEQUALIS REVERSED SHOULDER PROSTHESIS2010-05-06

Adverse events under product code HSX

product code HSX

Injury: 1,003
Other: 1
Total: 1,004

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.