Cleared Traditional

K122822 - SPECTRUM SPINE LAMINOPLASTY PLATING SYSTEM

K122822 is an FDA 510(k) clearance for SPECTRUM SPINE LAMINOPLASTY PLATING SYSTEM, manufactured by Spectrum Spine, LLC. The device is a Class 2 Orthopedic device with product code NQW cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K122822 · Spectrum Spine, LLC · Orthopedic device
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Feb 2013
Decision
146d
Days
Class 2
Risk

K122822 is an FDA 510(k) clearance for the SPECTRUM SPINE LAMINOPLASTY PLATING SYSTEM. Classified as Orthosis, Spine, Plate, Laminoplasty, Metal (product code NQW), Class II - Special Controls.

Submitted by Spectrum Spine, LLC (Colorado Springs, US). The FDA issued a Cleared decision on February 7, 2013 after a review of 146 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 Spectrum Spine, LLC devices

FDA 510(k) Submission Details - K122822

510(k) Number K122822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2012
Decision Date February 07, 2013
Days to Decision 146 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
24d slower than avg
Panel avg: 122d · This submission: 146d
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 25
Devices cleared under the same product code (NQW) and FDA review panel - the closest regulatory comparables to K122822.
Integra Laminoplasty System
K150469 · Seaspine, Inc. · Mar 2015
SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEM
K132740 · Spinefrontier, Inc. · Nov 2013
INTEGRA LAMINOPLASTY SYSTEM
K130830 · Seaspine, Inc. · May 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