SPREADER— 510(k) K781445

Substantially Equivalent

Orthopedic Equipment Co., Inc.

FDA 510(k) clearance K781445 for SPREADER, Substantially Equivalent on 1979-09-27. Applicant: Orthopedic Equipment Co., Inc..

Clearance details

Applicant: Orthopedic Equipment Co., Inc.
Product code: Code GAD
Advisory panel: General, Plastic Surgery
Date received: 1978-08-23
Decision date: 1979-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GAD

product code GAD

Malfunction: 504
Total: 504

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.