SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVERY SCREWS, MODEL PLS.01.T5.X— 510(k) K043355

Name: FDA 510(k) clearance K043355
Creator: U.S. Food and Drug Administration
Published: 2004-12-17

Substantially Equivalent

Sintea Biotech, Inc.

FDA 510(k) clearance K043355 for SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVERY SCREWS, MODEL PLS.01.T5.X, Substantially Equivalent on 2004-12-17. Applicant: Sintea Biotech, Inc.. Device class: 2.

Clearance details

Applicant: Sintea Biotech, Inc.
Product code: Code KWP
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2004-12-06
Decision date: 2004-12-17
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 KWP

product code KWP

Death: 7
Injury: 1,539
Malfunction: 1,519
Total: 3,065

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.