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FDA 510(k)

4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM

K-Number: K102458 · 2011-06-13

ApplicantSolco Biomedical Co., Ltd.
Decision Date2011-06-13
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON 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 2011-06-13 under 510(k) number K102458. 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 SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM?

4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM is a medical device that received FDA 510(k) clearance on 2011-06-13. The listed applicant is Solco Biomedical Co., Ltd.. The 510(k) number is K102458.

When did 4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM receive FDA 510(k) clearance?

4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM received FDA 510(k) clearance on 2011-06-13, under 510(k) number K102458.

Who is the listed applicant for 4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON 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 SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM?

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

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Related Devices (Code: MNH)

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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.

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