K070181

Substantially Equivalent

SINTEA BIOTECH DSC/ALF SPINAL SYSTEM, DSC.XX.T5.XX, ALF.XX.T5.XX

Applicant: Sintea Biotech, Inc.
Product code: MQP
Advisory panel: Orthopedic
Date received: 2007-01-19
Decision date: 2007-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami Beach, FL, US

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.