RESOLUTE FACET SCREW SYSTEM— 510(k) K121551

Name: FDA 510(k) clearance K121551
Creator: U.S. Food and Drug Administration
Published: 2012-10-23

Substantially Equivalent

Neurostructures, LLC

FDA 510(k) clearance K121551 for RESOLUTE FACET SCREW SYSTEM, Substantially Equivalent on 2012-10-23. Applicant: Neurostructures, LLC. Device class: Unclassified.

Clearance details

Applicant: Neurostructures, LLC
Product code: Code MRW
Device class: Unclassified
Advisory panel: Unknown
Date received: 2012-05-25
Decision date: 2012-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Colorado Springs, CO, 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 Neurostructures, LLC

view all

K131374 — TEMPUS(TM) CERVICAL PLATE SYSTEM2013-08-23
K120515 — TEMPUS CERVICAL PLATE SYSTEM2012-05-23

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