Reliance Spinal Screw System
K-Number: K162066 · 2016-12-02
ApplicantReliance Medical Systems, LLC
Decision Date2016-12-02
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Reliance Spinal Screw System is a medical device manufactured by Reliance Medical Systems, LLC. It received FDA 510(k) clearance on 2016-12-02 under approval number K162066. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Reliance Spinal Screw System?
Reliance Spinal Screw System is a medical device that received FDA 510(k) clearance on 2016-12-02. It is manufactured by Reliance Medical Systems, LLC. The 510(k) number is K162066.
When was Reliance Spinal Screw System approved by the FDA?
Reliance Spinal Screw System received FDA 510(k) clearance on 2016-12-02, under approval number K162066.
What company makes Reliance Spinal Screw System?
Reliance Spinal Screw System is manufactured by Reliance Medical Systems, LLC.
What is the FDA product code for Reliance Spinal Screw System?
The FDA product code for Reliance Spinal Screw System is MNH. This falls under the ENT category.
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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.