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

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..

Clearance details

Applicant: Sintea Biotech, Inc.
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 2004-12-06
Decision date: 2004-12-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Miami Beach, FL, US

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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.