Spinal fixation system
K-Number: K161151 · 2016-09-21
ApplicantCanwell Medical Co., Ltd.
Decision Date2016-09-21
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Spinal fixation system is a medical device manufactured by Canwell Medical Co., Ltd.. It received FDA 510(k) clearance on 2016-09-21 under approval number K161151. 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 Spinal fixation system?
Spinal fixation system is a medical device that received FDA 510(k) clearance on 2016-09-21. It is manufactured by Canwell Medical Co., Ltd.. The 510(k) number is K161151.
When was Spinal fixation system approved by the FDA?
Spinal fixation system received FDA 510(k) clearance on 2016-09-21, under approval number K161151.
What company makes Spinal fixation system?
Spinal fixation system is manufactured by Canwell Medical Co., Ltd..
What is the FDA product code for Spinal fixation system?
The FDA product code for Spinal fixation 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.