SCS CLARIS SPINAL SCREWS, TYPES V,G,E— 510(k) K011807

Name: FDA 510(k) clearance K011807
Creator: U.S. Food and Drug Administration
Published: 2001-08-07

Substantially Equivalent

Ortho Tec, LLC

FDA 510(k) clearance K011807 for SCS CLARIS SPINAL SCREWS, TYPES V,G,E, Substantially Equivalent on 2001-08-07. Applicant: Ortho Tec, LLC. Device class: 2.

Clearance details

Applicant: Ortho Tec, LLC
Product code: Code MNI
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2001-06-11
Decision date: 2001-08-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Chesterland, OH, US

Download summary PDF View on FDA.gov ↗

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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.