ORIA SPINAL CLIP SYSTEM, TYPES BD AND BJ— 510(k) K023994

Substantially Equivalent

Ortho Tec, LLC

FDA 510(k) clearance K023994 for ORIA SPINAL CLIP SYSTEM, TYPES BD AND BJ, Substantially Equivalent on 2003-02-05. Applicant: Ortho Tec, LLC.

Clearance details

Applicant: Ortho Tec, LLC
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 2002-12-03
Decision date: 2003-02-05
Decision: Substantially Equivalent
Clearance type: Special
Location: California, CA, US

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Adverse events under product code MNH

product code MNH

Injury: 978
Malfunction: 793
Total: 1,771

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.