510(k) K970751— HEIDELBERG EXTERNAL FIXATOR

Substantially Equivalent

Smith & Nephew, Inc., Orthopaedic Div.

Clearance details

Applicant: Smith & Nephew, Inc., Orthopaedic Div.
Product code: Code JDW
Advisory panel: Orthopedic
Date received: 1997-03-03
Decision date: 1997-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Adverse events under product code JDW

product code JDW

Injury: 717
Total: 717

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.