510(k) K063764— SOUTHERN SPINE ANTERIOR CERVICAL STABILIZATION SYSTEM, KWIK- FIX CERVICAL SYSTEM, AND KWIK-FIX / TS CERVICAL SYSTEM

Substantially Equivalent

Southern Spine, LLC

Clearance details

Applicant: Southern Spine, LLC
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 2006-12-20
Decision date: 2007-05-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Alpharetta, GA, US

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.