LUCENT OR LUCENT MAGNUM— 510(k) K110632

Clearance details

Applicant

Spinal Elements, Inc.

Product code

Code MAX

Device class

Class 2

Regulation

21 CFR 888.3080

Advisory panel

Orthopedic

Date received

2011-03-04

Decision date

2012-05-23

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Carlsbad, CA, US

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• K243916 — Primus Spinal Fixation System2025-02-21

Death

13

Injury

1,305

Malfunction

2,885

Total

4,203

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0907-2015 — Ti-Bond Marketing Literature/Labeling, Catalog No. LT10000, MP-14000 This device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device.Class II·Terminated·Spinal Elements, Inc·20141218

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110632.