FDA 510(k)

OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM

K-Number: K092395 · 2009-11-19

Decision Date2009-11-19

Product CodeJXG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Integra Lifesciences Corp.. It received FDA 510(k) clearance on 2009-11-19 under 510(k) number K092395. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM?

OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM is a medical device that received FDA 510(k) clearance on 2009-11-19. The listed applicant is Integra Lifesciences Corp.. The 510(k) number is K092395.

When did OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM receive FDA 510(k) clearance?

OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM received FDA 510(k) clearance on 2009-11-19, under 510(k) number K092395.

Who is the listed applicant for OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM?

The FDA 510(k) record lists Integra Lifesciences Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM?

The FDA product code for OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM is JXG.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.