Cleared Traditional

K091623 - LAMINOPLASTY FIXATION SYSTEM

K091623 is an FDA 510(k) clearance for LAMINOPLASTY FIXATION SYSTEM, manufactured by Nuvasive, Inc.. The device is a Class 2 Orthopedic device with product code NQW cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K091623 · Nuvasive, Inc. · Orthopedic device
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Oct 2009
Decision
128d
Days
Class 2
Risk

K091623 is an FDA 510(k) clearance for the LAMINOPLASTY FIXATION SYSTEM. Classified as Orthosis, Spine, Plate, Laminoplasty, Metal (product code NQW), Class II - Special Controls.

Submitted by Nuvasive, Inc. (San Diego, US). The FDA issued a Cleared decision on October 9, 2009 after a review of 128 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 Nuvasive, Inc. devices

FDA 510(k) Submission Details - K091623

510(k) Number K091623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2009
Decision Date October 09, 2009
Days to Decision 128 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 122d · This submission: 128d
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 K091623.
PIONEER RELEASE LAMINOPLASTY PLATING SYSTEM
K113218 · Pioneer Surgical Technology, Inc. · Jan 2012
LAMINOPLASY PLATING SYSTEM
K103284 · Aesculap Implant Systems, Inc. · Dec 2010
MOUNTAINEER LAMINOPLASTY SYSTEM
K091994 · Depuy Spine, Inc. · Jan 2010
LAMINOPLASTY PLATING SYSTEM
K090354 · Aesculap Implant System, Inc. · May 2009
RELIEVE LAMINOPLASTY FIXATION SYSTEM
K080664 · Globus Medical, Inc. · Jul 2008
CENTERPIECE PLATE FIXATION SYSTEM
K050082 · Medtronic Sofamor Danek, Inc. · Jun 2005