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FDA 510(k)

4CIS VANE SPINE SYSTEM

K-Number: K101818 · 2011-02-11

ApplicantSolco Biomedical Co., Ltd.
Decision Date2011-02-11
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

4CIS VANE SPINE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Solco Biomedical Co., Ltd.. It received FDA 510(k) clearance on 2011-02-11 under 510(k) number K101818. 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 4CIS VANE SPINE SYSTEM?

4CIS VANE SPINE SYSTEM is a medical device that received FDA 510(k) clearance on 2011-02-11. The listed applicant is Solco Biomedical Co., Ltd.. The 510(k) number is K101818.

When did 4CIS VANE SPINE SYSTEM receive FDA 510(k) clearance?

4CIS VANE SPINE SYSTEM received FDA 510(k) clearance on 2011-02-11, under 510(k) number K101818.

Who is the listed applicant for 4CIS VANE SPINE SYSTEM?

The FDA 510(k) record lists Solco Biomedical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 4CIS VANE SPINE SYSTEM?

The FDA product code for 4CIS VANE SPINE SYSTEM is MNH. This falls under the ENT category.

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Related Devices (Code: MNH)

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K162066Reliance Spinal Screw SystemReliance Medical Systems, LLCK162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd.K162143FixxSure® X-LinkInnovasis, Inc.K161151Spinal fixation systemCanwell Medical Co., Ltd.K162189ANAX™ 5.5 Spinal SystemU&I CorporationK151362HC Spinal SystemHung Chun Bio-S Co., Ltd.

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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