SYNTHES CRANIAL SPRING CLIP (CSC)— 510(k) K974206

Substantially Equivalent

Synthes (Usa)

FDA 510(k) clearance K974206 for SYNTHES CRANIAL SPRING CLIP (CSC), Substantially Equivalent on 1998-03-16. Applicant: Synthes (Usa).

Clearance details

Applicant: Synthes (Usa)
Product code: Code GWO
Advisory panel: Neurology
Date received: 1997-11-10
Decision date: 1998-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paoli, PA, US

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Adverse events under product code GWO

product code GWO

Malfunction: 583
Total: 583

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.