5.0MM SPINAL SCREWS— 510(k) K994288

Substantially Equivalent

Ortho Tec, LLC

FDA 510(k) clearance K994288 for 5.0MM SPINAL SCREWS, Substantially Equivalent on 2000-04-10. Applicant: Ortho Tec, LLC.

Clearance details

Applicant: Ortho Tec, LLC
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 1999-12-20
Decision date: 2000-04-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Pleasant Hill, 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.