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Nextgen Altius Oct System

by Biomet Spine (Aka Ebi, LLC) 2 variants

510(k) K122378

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK122378 Date20 Sep 2012ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2759-2015 FDA Class II initiated 22 Jul 2015

    Biomet has initiated a recall on Biomet Spine Lineum OCC Starter Flexible and its inner shaft instrumentsafter identifying that these instruments were distributed prior to completion of all design control activities.

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  • Withdrawn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
KWP
Device Class
Class II
Regulation
21 CFR Part 888.3050
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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