SINTEA BIOTECH SCHANZ SCREW, MODEL TFX.SS.XX.X— 510(k) K031154

Substantially Equivalent

Sintea Biotech, Inc.

FDA 510(k) clearance K031154 for SINTEA BIOTECH SCHANZ SCREW, MODEL TFX.SS.XX.X, Substantially Equivalent on 2003-06-24. Applicant: Sintea Biotech, Inc..

Clearance details

Applicant: Sintea Biotech, Inc.
Product code: Code JDW
Advisory panel: Orthopedic
Date received: 2003-04-11
Decision date: 2003-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami Beach, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JDW

product code JDW

Injury: 717
Total: 717

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.