TRINICA SELECT ANTERIOR CERVICAL PLATE SYSTEM— 510(k) K022344

Substantially Equivalent

Centerpulse Spine-Tech, Inc.

FDA 510(k) clearance K022344 for TRINICA SELECT ANTERIOR CERVICAL PLATE SYSTEM, Substantially Equivalent on 2002-09-24. Applicant: Centerpulse Spine-Tech, Inc..

Clearance details

Applicant: Centerpulse Spine-Tech, Inc.
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 2002-07-19
Decision date: 2002-09-24
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.