AEQUALIS HUMERAL PLATE— 510(k) K063551

Name: FDA 510(k) clearance K063551
Creator: U.S. Food and Drug Administration
Published: 2006-12-22

Substantially Equivalent

Tornier

FDA 510(k) clearance K063551 for AEQUALIS HUMERAL PLATE, Substantially Equivalent on 2006-12-22. Applicant: Tornier. Device class: 2.

Clearance details

Applicant: Tornier
Product code: Product code KTT
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2006-11-24
Decision date: 2006-12-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Saint-Ismier Cedex, FR

Download summary PDF View on FDA.gov ↗

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K260112 — QuikFix External Fixator: Knee-Spanning Pack2026-03-23
K253291 — Excelsior System2026-01-20

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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 KTT

product code KTT

Death: 11
Injury: 3,097
Malfunction: 1,261
Total: 4,369

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.