SINTEA BIOTECH DSC/ALF SPINAL SYSTEM, DSC.XX.T5.XX, ALF.XX.T5.XX— 510(k) K070181

Name: FDA 510(k) clearance K070181
Creator: U.S. Food and Drug Administration
Published: 2007-04-18

Substantially Equivalent

Sintea Biotech, Inc.

FDA 510(k) clearance K070181 for SINTEA BIOTECH DSC/ALF SPINAL SYSTEM, DSC.XX.T5.XX, ALF.XX.T5.XX, Substantially Equivalent on 2007-04-18. Applicant: Sintea Biotech, Inc.. Device class: 2.

Clearance details

Applicant: Sintea Biotech, Inc.
Product code: Code MQP
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2007-01-19
Decision date: 2007-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami Beach, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MQP

product code MQP

Injury: 372
Malfunction: 519
Total: 891

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.