510(k) K020085— SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM, MODEL PLS 00.T5.X

Substantially Equivalent

Sintea Biotech, Inc.

Clearance details

Applicant: Sintea Biotech, Inc.
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 2002-01-10
Decision date: 2002-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami Beach, FL, US

Adverse events under product code MNH

product code MNH

Injury: 978
Malfunction: 793
Total: 1,771

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.