Osv II Lumbar Valve System and Osv II Low Flow Lumbar Valve System
FDA 510(k) K092395 · Integra Lifesciences Corp.
510(k) numberK092395
Submission
- Device name
- Osv II Lumbar Valve System and Osv II Low Flow Lumbar Valve System
- Applicant
- Integra Lifesciences Corp.
Planisboro, NJ, US - Received
- August 5, 2009
- Decision date
- November 19, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Osv II Lumbar Valve System and Osv II Low Flow Lumbar Valve System cleared by the FDA?
Osv II Lumbar Valve System and Osv II Low Flow Lumbar Valve System (K092395) received a 510(k) decision of Substantially Equivalent on November 19, 2009, 106 days after the submission was received.
What is the product code of K092395?
The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.