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FDA 510(k)

NOVEL SPINAL SYSTEM

K-Number: K081153 · 2009-01-30

ApplicantMedyssey Co, Ltd.
Decision Date2009-01-30
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NOVEL SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medyssey Co, Ltd.. It received FDA 510(k) clearance on 2009-01-30 under 510(k) number K081153. 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 NOVEL SPINAL SYSTEM?

NOVEL SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2009-01-30. The listed applicant is Medyssey Co, Ltd.. The 510(k) number is K081153.

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

NOVEL SPINAL SYSTEM received FDA 510(k) clearance on 2009-01-30, under 510(k) number K081153.

Who is the listed applicant for NOVEL SPINAL SYSTEM?

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

What is the FDA product code for NOVEL SPINAL SYSTEM?

The FDA product code for NOVEL SPINAL SYSTEM is MNH. This falls under the ENT category.

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Other records listing Medyssey Co, Ltd. as applicant

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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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