AEQUALIS SHOULDER SYSTEM— 510(k) K063081

Name: FDA 510(k) clearance K063081
Creator: U.S. Food and Drug Administration
Published: 2006-11-09

Substantially Equivalent

Tornier

FDA 510(k) clearance K063081 for AEQUALIS SHOULDER SYSTEM, Substantially Equivalent on 2006-11-09. Applicant: Tornier. Device class: 2.

Clearance details

Applicant: Tornier
Product code: Code HSD
Device class: Class 2
Regulation: 21 CFR 888.3690
Advisory panel: Orthopedic
Date received: 2006-10-10
Decision date: 2006-11-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Monbonnot Saint Martin, FR

Download summary PDF View on FDA.gov ↗

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More clearances from Tornier

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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 HSD

product code HSD

Injury: 3,425
Malfunction: 531
Total: 3,956

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.