MOUNTAINEER LAMINOPLASTY SYSTEM— 510(k) K091994

Name: FDA 510(k) clearance K091994
Creator: U.S. Food and Drug Administration
Published: 2010-01-07

Substantially Equivalent

Depuy Spine, Inc.

FDA 510(k) clearance K091994 for MOUNTAINEER LAMINOPLASTY SYSTEM, Substantially Equivalent on 2010-01-07. Applicant: Depuy Spine, Inc.. Device class: 2.

Clearance details

Applicant: Depuy Spine, Inc.
Product code: Code NQW
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2009-07-02
Decision date: 2010-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raynham, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NQW

view all

K252930 — AQUA Laminoplasty Systems2026-05-27
K243137 — Curiteva Porous PEEK Laminoplasty System2024-10-28
K242784 — Vy Spine VyLam Laminoplasty System2024-10-16
K232471 — Vy Spine VyLam Laminoplasty System2023-10-10
K231232 — Curiteva Laminoplasty System2023-06-28

More clearances from Depuy Spine, Inc.

view all

K201831 — CONFIDENCE Spinal Cement System2020-08-31
K142185 — EXPEDIUM VERSE SPINE SYSTEM2014-11-19
K111136 — EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM2012-06-14
K121020 — VIPER SYSTEM2012-05-03
K110353 — MOUNTAINEER OCT SPINAL SYSTEM2011-04-07

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