LEUCADIA AUTOLOK PEDICLE SCREW SYSTEM— 510(k) K113366

Clearance details

Applicant

Phygen, LLC

Product code

Code NKB

Device class

Class 2

Regulation

21 CFR 888.3070

Advisory panel

Orthopedic

Date received

2011-11-15

Decision date

2012-01-17

Decision

Substantially Equivalent

Clearance type

Special

Location

Irvine, CA, US

• K262091 — FRAXION Spinal Fixation System2026-09-17
• K262193 — RIVA® Posterior Fixation System with NanoACTIV Surface Technology +1 more2026-09-14
• K262828 — KHEIRON® Spinal Fixation System, including patient specific K-ROD2026-09-04
• K253943 — Tiger 2 System2026-07-24
• K260362 — QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)2026-07-24

• K120355 — LEUCADIA 4.5 MM PEDICLE SCREW SYSTEM2012-03-07
• K112931 — LEUCADIA(TM) MIS PEDICLE SCREW SYSTEM2011-11-02
• K110679 — DEL MAR MONOAXIAL PEDICLE SCREW SYSTEM2011-08-02
• K110588 — LEUCADIA PEDICLE SCREW SYSTEM2011-05-25
• K103748 — LAGUNA PEDICLE SCREW SYSTEM2011-03-02

Death

27

Injury

5,033

Malfunction

4,140

Total

9,200

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-1421-2013 — Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide correction, immobilization and stabilization of spinal segments.Class II·Terminated·Alphatec Spine, Inc.·20130506

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K113366.