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FDA 510(k)

4CIS SOLAR AND APOLLON SPINE SYSTEMS

K-Number: K082453 · 2008-09-23

ApplicantSolco Biomedical Co., Ltd.
Decision Date2008-09-23
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

4CIS SOLAR AND APOLLON SPINE SYSTEMS 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 2008-09-23 under 510(k) number K082453. 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 AND APOLLON SPINE SYSTEMS?

4CIS SOLAR AND APOLLON SPINE SYSTEMS is a medical device that received FDA 510(k) clearance on 2008-09-23. The listed applicant is Solco Biomedical Co., Ltd.. The 510(k) number is K082453.

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

4CIS SOLAR AND APOLLON SPINE SYSTEMS received FDA 510(k) clearance on 2008-09-23, under 510(k) number K082453.

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

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 AND APOLLON SPINE SYSTEMS?

The FDA product code for 4CIS SOLAR AND APOLLON SPINE SYSTEMS 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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