SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06— 510(k) K021379

Substantially Equivalent

Ortho Tec, LLC

FDA 510(k) clearance K021379 for SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06, Substantially Equivalent on 2002-05-31. Applicant: Ortho Tec, LLC.

Clearance details

Applicant: Ortho Tec, LLC
Product code: Code MNI
Advisory panel: Orthopedic
Date received: 2002-05-01
Decision date: 2002-05-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Chesterland, OH, US

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Adverse events under product code MNI

product code MNI

Injury: 641
Total: 641

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.