K031452

Substantially Equivalent

ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03

Applicant: Ortho Tec, LLC
Product code: KWP
Advisory panel: Orthopedic
Date received: 2003-05-07
Decision date: 2003-06-18
Decision: Substantially Equivalent
Clearance type: Special
Location: California, CA, US

Adverse events under product code KWP

product code KWP

Death: 7
Injury: 1,539
Malfunction: 1,519
Total: 3,065

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.