ARICULATED TENSION DEVICE SYNTHES TEN— 510(k) K792253

Substantially Equivalent

Synthes (Usa)

FDA 510(k) clearance K792253 for ARICULATED TENSION DEVICE SYNTHES TEN, Substantially Equivalent on 1979-12-05. Applicant: Synthes (Usa).

Clearance details

Applicant: Synthes (Usa)
Product code: Code HWN
Advisory panel: Orthopedic
Date received: 1979-11-07
Decision date: 1979-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code HWN

product code HWN

Malfunction: 586
Total: 586

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.