CARPAL ENGAGING WRIST FUSION PLATE— 510(k) K974030

Substantially Equivalent

Terray Corp.

FDA 510(k) clearance K974030 for CARPAL ENGAGING WRIST FUSION PLATE, Substantially Equivalent on 1998-01-21. Applicant: Terray Corp..

Clearance details

Applicant: Terray Corp.
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 1997-10-23
Decision date: 1998-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ontario, CA

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.