RADIAL HEAD PROSTHESIS— 510(k) K811451

Name: FDA 510(k) clearance K811451
Creator: U.S. Food and Drug Administration
Published: 1981-06-09

Substantially Equivalent

Cintor Orthopaedic Div.

FDA 510(k) clearance K811451 for RADIAL HEAD PROSTHESIS, Substantially Equivalent on 1981-06-09. Applicant: Cintor Orthopaedic Div.. Device class: 2.

Clearance details

Applicant: Cintor Orthopaedic Div.
Product code: Code JDB
Device class: Class 2
Regulation: 21 CFR 888.3160
Advisory panel: Orthopedic
Date received: 1981-05-22
Decision date: 1981-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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.