ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM— 510(k) K042673

Clearance details

Applicant

Alphatec/Nexmed

Product code

Code KWP

Device class

Class 2

Regulation

21 CFR 888.3050

Advisory panel

Orthopedic

Date received

2004-09-29

Decision date

2004-10-27

Decision

Substantially Equivalent

Clearance type

Special

Location

Carlsbad, CA, US

• K143278 — LnK Posterior Cervical Fixation System2015-07-29
• K150753 — OASYS System2015-06-09
• K150851 — Sure Lok Mini Posterior Cervical/Upper Thoracic System2015-06-04
• K142867 — Reliance Posterior Cervical-Thoracic System2015-04-29
• K150254 — Streamline OCT Occipito-Cervico-Thoracic System2015-04-28

• K050830 — ZODIAC SPINAL FIXATION SYSTEM2005-06-22
• K051286 — ZODIAC SPINAL FIXATION SYSTEM2005-06-17
• K050553 — NOVEL VBR SPINAL SYSTEM2005-04-18
• K050390 — TAMARACK ANTERIOR THORACOLUNBAR2005-03-14
• K050078 — ROC LUMBAR PLATING SYSTEM2005-02-18

Death

7

Injury

1,539

Malfunction

1,519

Total

3,065

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-0168-2013 — ILLlCO¿ MIS Posterior Fixation System, Bone-screw Internal Spinal Fixation System, Orthosis, Spinal Pedical Fixation Orthosis, Spondylolisthesis Spinal Fixation The ILLICO MIS Posterior Fixation System is intended to facilitate the surgical correction of noncervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. When used for a minimally invasive posterior approach ILLlCO¿ MIS Instrumentation is used in conjunction with polyaxial screw components. The ILLICO MIS Posterior Fixation System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the ILLICO MIS Posterior Fixation System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.Class II·Terminated·Alphatec Spine, Inc.·20120925
• Z-0967-2013 — ILLICO Straight CP TI Rod, -5.5MM x 110M; REF#73601-110; Qty 1; LBL-005; REV.B; RX ONLY; Alphatec Spine, Inc. The ILLICO¿ MIS Posterior Spinal Fixation System is intended to facilitate the surgical correction of non-cervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development.Class II·Terminated·Alphatec Spine, Inc.·20110706

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K042673.