RHS— 510(k) K060438

Name: FDA 510(k) clearance K060438
Creator: U.S. Food and Drug Administration
Published: 2006-04-18

Substantially Equivalent

Tornier

FDA 510(k) clearance K060438 for RHS, Substantially Equivalent on 2006-04-18. 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: 2006-02-21
Decision date: 2006-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monbonnot Saint Martin, 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.