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FDA 510(k)

4CIS VANE SPINE SYSTEM

K-Number: K121615 · 2012-08-15

ApplicantSolco Biomedical Co., Ltd.
Decision Date2012-08-15
Product CodeMNI
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 2012-08-15 under 510(k) number K121615. The device is classified under product code MNI. It was reviewed by the OR advisory panel. 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 2012-08-15. The listed applicant is Solco Biomedical Co., Ltd.. The 510(k) number is K121615.

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

4CIS VANE SPINE SYSTEM received FDA 510(k) clearance on 2012-08-15, under 510(k) number K121615.

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 MNI.

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Related Devices (Code: MNI)

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K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co. , Ltd.K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd.K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc.K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.K160320PremierShandong Weigao Orthopaedic Device 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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