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FDA 510(k)

RANGE SPINAL SYSTEM (MESA AND DENALI)

K-Number: K121016 · 2012-06-27

ApplicantK2m, Inc.
Decision Date2012-06-27
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RANGE SPINAL SYSTEM (MESA AND DENALI) is the device name listed in this FDA 510(k) record. The listed applicant is K2m, Inc.. It received FDA 510(k) clearance on 2012-06-27 under 510(k) number K121016. 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 RANGE SPINAL SYSTEM (MESA AND DENALI)?

RANGE SPINAL SYSTEM (MESA AND DENALI) is a medical device that received FDA 510(k) clearance on 2012-06-27. The listed applicant is K2m, Inc.. The 510(k) number is K121016.

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

RANGE SPINAL SYSTEM (MESA AND DENALI) received FDA 510(k) clearance on 2012-06-27, under 510(k) number K121016.

Who is the listed applicant for RANGE SPINAL SYSTEM (MESA AND DENALI)?

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 RANGE SPINAL SYSTEM (MESA AND DENALI)?

The FDA product code for RANGE SPINAL SYSTEM (MESA AND DENALI) is MNH. This falls under the ENT category.

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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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