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FDA 510(k)

MEGA 5.5 SPINE SYSTEM

K-Number: K123476 · 2013-01-08

ApplicantLsk Biopartners, Inc.
Decision Date2013-01-08
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MEGA 5.5 SPINE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Lsk Biopartners, Inc.. It received FDA 510(k) clearance on 2013-01-08 under 510(k) number K123476. 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 MEGA 5.5 SPINE SYSTEM?

MEGA 5.5 SPINE SYSTEM is a medical device that received FDA 510(k) clearance on 2013-01-08. The listed applicant is Lsk Biopartners, Inc.. The 510(k) number is K123476.

When did MEGA 5.5 SPINE SYSTEM receive FDA 510(k) clearance?

MEGA 5.5 SPINE SYSTEM received FDA 510(k) clearance on 2013-01-08, under 510(k) number K123476.

Who is the listed applicant for MEGA 5.5 SPINE SYSTEM?

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

What is the FDA product code for MEGA 5.5 SPINE SYSTEM?

The FDA product code for MEGA 5.5 SPINE SYSTEM is MNH. This falls under the ENT category.

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Related Devices (Code: MNH)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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