SCS CLARIS SPINAL SYSTEM,REXTENDED OMNIAXIAL CONNECTOR-,MEDIUM, MODEL CO05, SCS CLARIS SPINAL SYSTEM,EXTENDED OMNIAXIALO— 510(k) K021919

Substantially Equivalent

Ortho Tec, LLC

FDA 510(k) clearance K021919 for SCS CLARIS SPINAL SYSTEM,REXTENDED OMNIAXIAL CONNECTOR-,MEDIUM, MODEL CO05, SCS CLARIS SPINAL SYSTEM,EXTENDED OMNIAXIALO, Substantially Equivalent on 2002-07-03. Applicant: Ortho Tec, LLC.

Clearance details

Applicant: Ortho Tec, LLC
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 2002-06-11
Decision date: 2002-07-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Chesterland, OH, US

Download summary PDF View on FDA.gov ↗

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.