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Aleutian System

by K2M, Inc.

510(k) K113138

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 NumberK113138 Date10 Jan 2012ClearedStatusActive

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  • Withdrawn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
MAX
Device class
Class II
Regulation
21 CFR Part 888.3080
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

The Aleutian IBF System is an orthopedic interbody fusion device designed for use in spinal fusion procedures. These implants are intended to be used with supplemental internal fixation systems appropriate for the implanted level, such as pedicle screw, hook, or spinal plate systems.

This device is manufactured by K2M, Inc. and has received FDA 510(k) clearance. It is categorized as a Class 2 orthopedic device.

Other devices from K2M, Inc.

See all devices from K2M, Inc. →

Questions

AI-generated answers, 6 Oct 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 primary purpose of the Aleutian IBF System?

    The Aleutian IBF System is an orthopedic interbody fusion device designed for use in spinal fusion procedures to facilitate stabilization and fusion.

  • Does the Aleutian IBF System require additional fixation hardware?

    The system is intended to be used in conjunction with supplemental internal fixation systems that are appropriate for the specific spinal level being treated, such as pedicle screws, hooks, or spinal plate systems.

  • What is the regulatory status of the Aleutian IBF System?

    The Aleutian IBF System is manufactured by K2M, Inc. and has received FDA 510(k) clearance, categorized as a Class 2 orthopedic device.