MODIFICATION TO TORNIER TOTAL ELBOW PROSTHESIS— 510(k) K031218

Name: FDA 510(k) clearance K031218
Creator: U.S. Food and Drug Administration
Published: 2003-05-16

Substantially Equivalent

Tornier

FDA 510(k) clearance K031218 for MODIFICATION TO TORNIER TOTAL ELBOW PROSTHESIS, Substantially Equivalent on 2003-05-16. Applicant: Tornier. Device class: 2.

Clearance details

Applicant: Tornier
Product code: Code JDB
Device class: Class 2
Regulation: 21 CFR 888.3160
Advisory panel: Orthopedic
Date received: 2003-04-17
Decision date: 2003-05-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Montbonnot, FR

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JDB

product code JDB

Injury: 352
Total: 352

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.