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FDA 510(k)

MESA SPINAL SYSTEM

K-Number: K080611 · 2009-03-04

ApplicantK2m, Inc.
Decision Date2009-03-04
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MESA SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is K2m, Inc.. It received FDA 510(k) clearance on 2009-03-04 under 510(k) number K080611. 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 MESA SPINAL SYSTEM?

MESA SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2009-03-04. The listed applicant is K2m, Inc.. The 510(k) number is K080611.

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

MESA SPINAL SYSTEM received FDA 510(k) clearance on 2009-03-04, under 510(k) number K080611.

Who is the listed applicant for MESA SPINAL SYSTEM?

The FDA 510(k) record lists K2m, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MESA SPINAL SYSTEM?

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

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Related Devices (Code: MNH)

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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