SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS— 510(k) K112611

Name: FDA 510(k) clearance K112611
Creator: U.S. Food and Drug Administration
Published: 2012-04-25

Substantially Equivalent

Sintea Plastek, LLC

FDA 510(k) clearance K112611 for SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS, Substantially Equivalent on 2012-04-25. Applicant: Sintea Plastek, LLC. Device class: 2.

Clearance details

Applicant: Sintea Plastek, LLC
Product code: Code MNI
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2011-09-07
Decision date: 2012-04-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Miami Beach, FL, 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.