UCR SPINAL SYSTEM— 510(k) K043232

Clearance details

Applicant

Seaspine

Product code

Code NKB

Device class

Class 2

Regulation

21 CFR 888.3070

Advisory panel

Orthopedic

Date received

2004-11-22

Decision date

2004-12-21

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Vista, CA, US

• 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
• K261284 — Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System2026-07-14
• K253802 — KHEIRON® Spinal Fixation System, including patient specific K-ROD2026-07-01

• K040130 — ANTERIOR LUMBAR BUTTRESS SYSTEM2004-03-26
• K032739 — UCR SPINAL SYSTEM2003-11-20
• K032368 — SONOMA ANTERIOR CERVICAL PLATE SYSTEM2003-10-09
• K031381 — UCR SPINAL SYSTEM, LAMINAR HOOKS, PEDICLE HOOKS, AND INSTRUMENTS2003-07-30

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-1841-2014 — Integra UCR 3mm Hex, Large Axial Driver. The UCR Hex Axial Driver is a surgical instrument used to implant and remove polyaxial screws of varying reduction heights provided with the Malibu", UCR, and NewPort" Systems. The Malibu", UCR, NewPort" Systems are intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of these systems. Indications For Use: The Malibu", UCR, NewPort" Systems are intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of these systems. The intended use of the Malibu, UCR, and NewPort Systems, when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.Class II·Terminated·SeaSpine Inc·20140521

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K043232.