Proficient (TM) Facet Screw Spine System— 510(k) K142980

Name: FDA 510(k) clearance K142980
Creator: U.S. Food and Drug Administration
Published: 2015-01-16

Substantially Equivalent

Spine Wave, Inc.

FDA 510(k) clearance K142980 for Proficient (TM) Facet Screw Spine System, Substantially Equivalent on 2015-01-16. Applicant: Spine Wave, Inc.. Device class: Unclassified.

Clearance details

Applicant: Spine Wave, Inc.
Product code: Code MRW
Device class: Unclassified
Advisory panel: Unknown
Date received: 2014-10-15
Decision date: 2015-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shelton, CT, 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 Spine Wave, Inc.

view all

K260286 — Dynamo Spinal Cement; Salvo® Spine System2026-06-15
K261159 — Exceed® Biplanar Expandable Interbody System2026-05-29
K243816 — Testa TP Pivoting Spacer System2025-06-27
K251131 — Annex® 2 Adjacent Level System2025-06-06
K243514 — Salvo® Robotic Navigation Instruments2025-04-03

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