CastleLoc Spinal Fixation System
K-Number: K162801 · 2016-11-03
ApplicantL&K BIOMED Co., Ltd.
Decision Date2016-11-03
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
CastleLoc Spinal Fixation System is a medical device manufactured by L&K BIOMED Co., Ltd.. It received FDA 510(k) clearance on 2016-11-03 under approval number K162801. 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 CastleLoc Spinal Fixation System?
CastleLoc Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2016-11-03. It is manufactured by L&K BIOMED Co., Ltd.. The 510(k) number is K162801.
When was CastleLoc Spinal Fixation System approved by the FDA?
CastleLoc Spinal Fixation System received FDA 510(k) clearance on 2016-11-03, under approval number K162801.
What company makes CastleLoc Spinal Fixation System?
CastleLoc Spinal Fixation System is manufactured by L&K BIOMED Co., Ltd..
What is the FDA product code for CastleLoc Spinal Fixation System?
The FDA product code for CastleLoc 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.