TORNIER TOTAL ELBOW PROSTHESIS— 510(k) K000003

Name: FDA 510(k) clearance K000003
Creator: U.S. Food and Drug Administration
Published: 2000-10-02

Substantially Equivalent

Tornier

FDA 510(k) clearance K000003 for TORNIER TOTAL ELBOW PROSTHESIS, Substantially Equivalent on 2000-10-02. Applicant: Tornier. Device class: 2.

Clearance details

Applicant: Tornier
Product code: Code JDC
Device class: Class 2
Regulation: 21 CFR 888.3150
Advisory panel: Orthopedic
Date received: 2000-01-03
Decision date: 2000-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasant Hill, CA, US

Download summary PDF View on FDA.gov ↗

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K181362 — TEMA Elbow System2019-02-16
K181307 — Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow2019-01-28
K153398 — Comprehensive SRS/Nexel Elbow2016-02-03
K150501 — Zimmer Nexel Total Elbow Ulnar Cement Diverter2015-04-23
K123862 — ZIMMER NEXEL TOTAL ELBOW2013-03-12

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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 JDC

product code JDC

Injury: 1,050
Total: 1,050

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.