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FDA 510(k)

MESA SPINAL SYSTEM (KEYSTONE RODS)

K-Number: K110991 · 2011-08-02

ApplicantK2m, Inc.
Decision Date2011-08-02
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MESA SPINAL SYSTEM (KEYSTONE RODS) is the device name listed in this FDA 510(k) record. The listed applicant is K2m, Inc.. It received FDA 510(k) clearance on 2011-08-02 under 510(k) number K110991. 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 MESA SPINAL SYSTEM (KEYSTONE RODS)?

MESA SPINAL SYSTEM (KEYSTONE RODS) is a medical device that received FDA 510(k) clearance on 2011-08-02. The listed applicant is K2m, Inc.. The 510(k) number is K110991.

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

MESA SPINAL SYSTEM (KEYSTONE RODS) received FDA 510(k) clearance on 2011-08-02, under 510(k) number K110991.

Who is the listed applicant for MESA SPINAL SYSTEM (KEYSTONE RODS)?

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 (KEYSTONE RODS)?

The FDA product code for MESA SPINAL SYSTEM (KEYSTONE RODS) is MNI.

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Related Devices (Code: MNI)

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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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