ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03— 510(k) K031452

Substantially Equivalent

Ortho Tec, LLC

FDA 510(k) clearance K031452 for ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03, Substantially Equivalent on 2003-06-18. Applicant: Ortho Tec, LLC.

Clearance details

Applicant: Ortho Tec, LLC
Product code: 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

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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.