SYNTHES RECONSTRUCTIVE PLATES 'Y' PLATES— 510(k) K792291

Substantially Equivalent

Synthes (Usa)

FDA 510(k) clearance K792291 for SYNTHES RECONSTRUCTIVE PLATES 'Y' PLATES, Substantially Equivalent on 1979-12-06. Applicant: Synthes (Usa).

Clearance details

Applicant: Synthes (Usa)
Product code: Code KTW
Advisory panel: Orthopedic
Date received: 1979-11-13
Decision date: 1979-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KTW

product code KTW

Injury: 220
Total: 220

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.