STRYKER INTRADISCAL RF GENERATOR— 510(k) K063489

Substantially Equivalent

Synergetics, Inc.

FDA 510(k) clearance K063489 for STRYKER INTRADISCAL RF GENERATOR, Substantially Equivalent on 2007-05-23. Applicant: Synergetics, Inc..

Clearance details

Applicant: Synergetics, Inc.
Product code: Code GXD
Advisory panel: Neurology
Date received: 2006-11-17
Decision date: 2007-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Valley Forge, PA, US

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Adverse events under product code GXD

product code GXD

Injury: 228
Total: 228

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.