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Aleutian IbF System

by K2M, Inc. 3 variants

510(k) K101302

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 NumberK101302 Date22 Jul 2010ClearedStatusActive

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  • Withdrawn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

Overview

AI-generated summary, 24 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 Aleutian IbF System is an orthopedic device. It is classified as a Class 2 device with product code ODP.

The Aleutian IbF System is supplied by K2M, Inc. and has received FDA 510K authorization. It is available with product code MAX and has undergone FDA review.

Other devices from K2M, Inc.

See all devices from K2M, Inc. →

Questions

AI-generated answers, 24 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 Aleutian IbF System used for?

    The Aleutian IbF System is an orthopedic device, indicating its use in orthopedic applications, but specific indications are not provided.

  • How is the Aleutian IbF System supplied?

    The Aleutian IbF System is supplied by K2M, Inc., with product code ODP, and has undergone FDA review.

  • Is the Aleutian IbF System a single-use or reusable device?

    The device data does not specify whether the Aleutian IbF System is for single-use or reuse.

  • What regulatory authorization has the Aleutian IbF System received?

    The Aleutian IbF System has received FDA 510K authorization, indicating it is substantially equivalent to a predicate device.