Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems
FDA 510(k) K161992 · Integra LifeSciences Corporation
510(k) numberK161992
Submission
- Device name
- Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems
- Applicant
- Integra LifeSciences Corporation
Planisboro, NJ, US - Received
- July 19, 2016
- Decision date
- September 22, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems cleared by the FDA?
Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems (K161992) received a 510(k) decision of Substantially Equivalent on September 22, 2016, 65 days after the submission was received.
What is the product code of K161992?
The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.