PRECISION SURGERY LIMITED VARIABLE AND FIXED CERVICAL PLATE SYSTEM— 510(k) K032815

Substantially Equivalent

Precision Surgery Limited

FDA 510(k) clearance K032815 for PRECISION SURGERY LIMITED VARIABLE AND FIXED CERVICAL PLATE SYSTEM, Substantially Equivalent on 2004-02-12. Applicant: Precision Surgery Limited.

Clearance details

Applicant: Precision Surgery Limited
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 2003-09-09
Decision date: 2004-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chesterland, OH, 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.