MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEM— 510(k) K012305

Substantially Equivalent

Sulzer Spine-Tech

FDA 510(k) clearance K012305 for MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEM, Substantially Equivalent on 2001-08-22. Applicant: Sulzer Spine-Tech.

Clearance details

Applicant: Sulzer Spine-Tech
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 2001-07-23
Decision date: 2001-08-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Minneapolis, MN, US

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.