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Omega LIF System

by Amendia, Inc.

510(k) K150395

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 · Traditional NumberK150395 Date10 Aug 2015ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1912-2018 FDA Class II initiated 16 Apr 2018

    Omega LIF interbody implants labeled as having 11 degrees of lordosis was assembled using components manufactured with 4 degrees of lordosis.

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  • Withdrawn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

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