GSB ELBOW— 510(k) K901581

Substantially Equivalent

Allo Pro Corp.

FDA 510(k) clearance K901581 for GSB ELBOW, Substantially Equivalent on 1990-10-22. Applicant: Allo Pro Corp..

Clearance details

Applicant: Allo Pro Corp.
Product code: Code JDC
Advisory panel: Orthopedic
Date received: 1990-04-04
Decision date: 1990-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JDC

product code JDC

Injury: 1,050
Total: 1,050

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.