FIXATION DEVICES AND BONE PLATE— 510(k) K913930

Substantially Equivalent

John M. Rayhack

FDA 510(k) clearance K913930 for FIXATION DEVICES AND BONE PLATE, Substantially Equivalent on 1991-10-04. Applicant: John M. Rayhack.

Clearance details

Applicant: John M. Rayhack
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 1991-08-22
Decision date: 1991-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.