SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM— 510(k) K132126

Name: FDA 510(k) clearance K132126
Creator: U.S. Food and Drug Administration
Published: 2013-10-28

Substantially Equivalent

Spectrum Spine, LLC

FDA 510(k) clearance K132126 for SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM, Substantially Equivalent on 2013-10-28. Applicant: Spectrum Spine, LLC. Device class: Unclassified.

Clearance details

Applicant: Spectrum Spine, LLC
Product code: Code MRW
Device class: Unclassified
Advisory panel: Unknown
Date received: 2013-07-10
Decision date: 2013-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waxhaw, NC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MRW

view all

K261209 — Ion-L2026-06-11
K253676 — CORUS Posterior Cervical Stabilization System 3D (CORUS PCSS 3D)2026-05-14
K253432 — DiversiVy Facet Screw System2026-03-19
K251714 — Ion-C2026-01-16
K250679 — FFX Facet Fixation System2025-12-04

More clearances from Spectrum Spine, LLC

view all

K201024 — Expandable Titanium PLIF/TLIF System2021-04-29
K173518 — Spectrum Spine Expandable Cages (SSEC)2019-03-07
K122822 — SPECTRUM SPINE LAMINOPLASTY PLATING SYSTEM2013-02-07

Data sourced from openFDA. This site is unofficial and independent of the FDA.