Spinal Elements' Spinous Process Plate System
K-Number: K160465 · 2016-07-28
ApplicantSpinal Elements, Inc.
Decision Date2016-07-28
Product CodePEK
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Spinal Elements' Spinous Process Plate System is a medical device manufactured by Spinal Elements, Inc.. It received FDA 510(k) clearance on 2016-07-28 under approval number K160465. The device is classified under product code PEK. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Spinal Elements' Spinous Process Plate System?
Spinal Elements' Spinous Process Plate System is a medical device that received FDA 510(k) clearance on 2016-07-28. It is manufactured by Spinal Elements, Inc.. The 510(k) number is K160465.
When was Spinal Elements' Spinous Process Plate System approved by the FDA?
Spinal Elements' Spinous Process Plate System received FDA 510(k) clearance on 2016-07-28, under approval number K160465.
What company makes Spinal Elements' Spinous Process Plate System?
Spinal Elements' Spinous Process Plate System is manufactured by Spinal Elements, Inc..
What is the FDA product code for Spinal Elements' Spinous Process Plate System?
The FDA product code for Spinal Elements' Spinous Process Plate System is PEK.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.