T-PLATE— 510(k) K931692

Substantially Equivalent for Some Indications

Onyx Medical Corp.

FDA 510(k) clearance K931692 for T-PLATE, Substantially Equivalent for Some Indications on 1994-05-04. Applicant: Onyx Medical Corp..

Clearance details

Applicant: Onyx Medical Corp.
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 1993-04-05
Decision date: 1994-05-04
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Memphis, TN, 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.