OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM— 510(k) K092395

Substantially Equivalent

Integra Lifesciences Corp.

FDA 510(k) clearance K092395 for OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM, Substantially Equivalent on 2009-11-19. Applicant: Integra Lifesciences Corp..

Clearance details

Applicant: Integra Lifesciences Corp.
Product code: Code JXG
Advisory panel: Neurology
Date received: 2009-08-05
Decision date: 2009-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Planisboro, NJ, US

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Adverse events under product code JXG

product code JXG

Death: 76
Injury: 5,632
Malfunction: 2,230
Other: 4
Total: 7,942

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.