Cleared Traditional

K121276 - NEURO VENTION LAMINPLASTY PLATING SYSTEM

K121276 is an FDA 510(k) clearance for NEURO VENTION LAMINPLASTY PLATING SYSTEM, manufactured by Neurovention, LLC. The device is a Class 2 Orthopedic device with product code NQW cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K121276 · Neurovention, LLC · Orthopedic device
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Aug 2012
Decision
124d
Days
Class 2
Risk

K121276 is an FDA 510(k) clearance for the NEURO VENTION LAMINPLASTY PLATING SYSTEM. Classified as Orthosis, Spine, Plate, Laminoplasty, Metal (product code NQW), Class II - Special Controls.

Submitted by Neurovention, LLC (Colorado Springs, US). The FDA issued a Cleared decision on August 29, 2012 after a review of 124 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Neurovention, LLC devices

FDA 510(k) Submission Details - K121276

510(k) Number K121276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2012
Decision Date August 29, 2012
Days to Decision 124 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 122d · This submission: 124d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NQW Device Classification - Class 2, Special Controls

Product Code NQW Orthosis, Spine, Plate, Laminoplasty, Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
Definition This Device Is A Plate That Is Attached To The Lamina After A Laminoplasty Or Laminectomy Procedure.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - NQW Orthosis, Spine, Plate, Laminoplasty, Metal

All 28
Devices cleared under the same product code (NQW) and FDA review panel - the closest regulatory comparables to K121276.
INTEGRA LAMINOPLASTY SYSTEM
K130830 · Seaspine, Inc. · May 2013
SPECTRUM SPINE LAMINOPLASTY PLATING SYSTEM
K122822 · Spectrum Spine, LLC · Feb 2013
CANOPY LAMINOPLASTY FIXATION SYSTEM
K121732 · Globus Medical, Inc. · Oct 2012
ESCALATE LAMINOPLASTY SYSTEM
K113802 · Stryker Spine · Apr 2012
PIONEER RELEASE LAMINOPLASTY PLATING SYSTEM
K113218 · Pioneer Surgical Technology, Inc. · Jan 2012
LAMINOPLASY PLATING SYSTEM
K103284 · Aesculap Implant Systems, Inc. · Dec 2010