FDA 510(k)

Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems

K-Number: K161992 · 2016-09-22

ApplicantIntegra LifeSciences Corporation

Decision Date2016-09-22

Product CodeJXG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems is a medical device manufactured by Integra LifeSciences Corporation. It received FDA 510(k) clearance on 2016-09-22 under approval number K161992. 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 Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems?

Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems is a medical device that received FDA 510(k) clearance on 2016-09-22. It is manufactured by Integra LifeSciences Corporation. The 510(k) number is K161992.

When was Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems approved by the FDA?

Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems received FDA 510(k) clearance on 2016-09-22, under approval number K161992.

What company makes Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems?

Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems is manufactured by Integra LifeSciences Corporation.

What is the FDA product code for Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems?

The FDA product code for Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems is JXG.

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Related Devices (Code: 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.