THORACIC ANTERIOR SPINAL FIXATION PLATE— 510(k) K910874

Substantially Equivalent

Terray Manufacturing, Inc.

FDA 510(k) clearance K910874 for THORACIC ANTERIOR SPINAL FIXATION PLATE, Substantially Equivalent on 1992-02-03. Applicant: Terray Manufacturing, Inc..

Clearance details

Applicant: Terray Manufacturing, Inc.
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 1991-03-01
Decision date: 1992-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ontario K7s 1l8, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

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.