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Lucent or Lucent Magnum

by Spinal Elements, Inc.

510(k) K110632

Lucent or Lucent Magnum is a Class II device made by Spinal Elements, Inc., cleared under FDA 510(k) K110632 on 23 May 2012, active as of 22 Oct 2026. One FDA recall is linked to it.

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK110632 Date23 May 2012ClearedStatusActive

Official records

Recalls

1 recall · FDA

    • Terminated Z-0907-2015 FDA Class II initiated 18 Dec 2014

    Spinal Elements is recalling the Ti-Bond related brochures that includes LT-10000 and MP-14000 (all revisions) the content regarding the Ti-Bond coating within the literature is unsubstantiated in context and/or misleading for the coating's use in spine applications.

Timeline

2 dated events

  1. Cleared FDA 510(k) K110632
  2. Recall initiated FDA recalls Z-0907-2015

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  • Withdrawn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

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

2 more clearances cite this device.

Source: 510k-lineage (choiben314), CC BY 4.0

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