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FDA 510(k)

4S SPINAL SYSTEM

K-Number: K063708 · 2007-04-24

ApplicantTaeyeon Medical Co., Ltd.
Decision Date2007-04-24
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

4S SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Taeyeon Medical Co., Ltd.. It received FDA 510(k) clearance on 2007-04-24 under 510(k) number K063708. 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 4S SPINAL SYSTEM?

4S SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2007-04-24. The listed applicant is Taeyeon Medical Co., Ltd.. The 510(k) number is K063708.

When did 4S SPINAL SYSTEM receive FDA 510(k) clearance?

4S SPINAL SYSTEM received FDA 510(k) clearance on 2007-04-24, under 510(k) number K063708.

Who is the listed applicant for 4S SPINAL SYSTEM?

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

What is the FDA product code for 4S SPINAL SYSTEM?

The FDA product code for 4S SPINAL SYSTEM is MNI.

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Other records listing Taeyeon Medical Co., Ltd. as applicant

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Related Devices (Code: MNI)

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.

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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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