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MESA Spinal System

by K2M, Inc.

510(k) K080611

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK080611 Date4 Mar 2009ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
MNH
Device class
Class II
Regulation
21 CFR Part 888.3070
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The MESA Spinal System is a spinal implant system designed to address complex spinal pathologies, including deformity correction. It features a variety of screw types and instrumentation, including 360° monoaxial screws, and incorporates Zero-Torque Technology for precise adjustments.

The system is supplied sterile and intended for single use. It is not indicated for use in patients with infections, pregnancy, metabolic disorders of calcified tissues, or other contraindications listed in the device data. The device is regulated under FDA 510(k) clearance.

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Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the MESA Spinal System used for?

    The MESA Spinal System is designed to address complex spinal pathologies, including deformity correction, using a variety of screw types and instrumentation.

  • Is the MESA Spinal System sterile and single-use?

    Yes, the system is supplied sterile and is intended for single use, meaning it should not be reused on another patient.

  • What is Zero-Torque Technology?

    Zero-Torque Technology is a feature of the MESA Spinal System that allows for precise adjustments during surgical procedures.

  • What are the contraindications for the MESA Spinal System?

    The system is not indicated for use in patients with infections, pregnancy, metabolic disorders of calcified tissues, or other contraindications listed in the device data.