SCS CLOSED SCREW— 510(k) K003733

Substantially Equivalent

Ortho Tec, LLC

FDA 510(k) clearance K003733 for SCS CLOSED SCREW, Substantially Equivalent on 2001-05-29. Applicant: Ortho Tec, LLC.

Clearance details

Applicant: Ortho Tec, LLC
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 2000-12-04
Decision date: 2001-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beverly Hills, 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.