SYNTHES 3.5 MM LOW PROFILE PELVIC RECONSTRUCTION PLATE— 510(k) K031573

Substantially Equivalent

Synthes (Usa)

FDA 510(k) clearance K031573 for SYNTHES 3.5 MM LOW PROFILE PELVIC RECONSTRUCTION PLATE, Substantially Equivalent on 2003-06-06. Applicant: Synthes (Usa).

Clearance details

Applicant: Synthes (Usa)
Product code: Code KTT
Advisory panel: Orthopedic
Date received: 2003-05-20
Decision date: 2003-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paoli, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KTT

product code KTT

Death: 11
Injury: 3,097
Malfunction: 1,261
Total: 4,369

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.