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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is L&K BIOMED Co., Ltd.. It received FDA 510(k) clearance on 2016-11-03 under 510(k) 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. The listed applicant is L&K BIOMED Co., Ltd.. The 510(k) number is K162801.

When did CastleLoc Spinal Fixation System receive FDA 510(k) clearance?

CastleLoc Spinal Fixation System received FDA 510(k) clearance on 2016-11-03, under 510(k) number K162801.

Who is the listed applicant for CastleLoc Spinal Fixation System?

The FDA 510(k) record lists L&K BIOMED Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing L&K BIOMED Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260840BluEX Cervical Expandable Cage SystemK261112CastleLoc-P Anterior Cervical Plate SystemK261130AccelFix Spinal Fixation SystemK260448CastleLoc Pectus Bar SystemK251940PathLoc Lumbar Plate SystemK251741PathLoc Lumbar Interbody Fusion Cage System

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Related Devices (Code: MNH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K162066Reliance Spinal Screw SystemReliance Medical Systems, LLCK162143FixxSure® X-LinkInnovasis, Inc.K161151Spinal fixation systemCanwell Medical Co., Ltd.K162189ANAX™ 5.5 Spinal SystemU&I CorporationK151362HC Spinal SystemHung Chun Bio-S Co., Ltd.K153404Zavation Spinal SystemZavation, LLC

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.

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