Cleared Traditional

K132740 - SPINEFRONTIER LESPLASTY POSTERIOR CERVI...

K132740 is the FDA 510(k) clearance for SPINEFRONTIER LESPLASTY POSTERIOR CERVI... by Spinefrontier, Inc.. It is a Class 2 Orthopedic device (product code NQW) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K132740 · Spinefrontier, Inc. · Orthopedic device
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Nov 2013
Decision
84d
Days
Class 2
Risk

K132740 is an FDA 510(k) clearance for the SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEM. Classified as Orthosis, Spine, Plate, Laminoplasty, Metal (product code NQW), Class II - Special Controls.

Submitted by Spinefrontier, Inc. (Beverly, US). The FDA issued a Cleared decision on November 26, 2013 after a review of 84 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Spinefrontier, Inc. devices

Submission Details

510(k) Number K132740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2013
Decision Date November 26, 2013
Days to Decision 84 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
38d faster than avg
Panel avg: 122d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 18
Devices cleared under the same product code (NQW) and FDA review panel - the closest regulatory comparables to K132740.
Life Spine Laminoplasty System
K181717 · Life Spine, Inc. · Oct 2018
Choice Spine Laminoplasty™ Fixation System
K173215 · Choicespine, LP · Jan 2018
HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System
K171413 · Globus Medical, Inc. · Jul 2017
CANOPY LAMINOPLASTY FIXATION SYSTEM
K121732 · Globus Medical, Inc. · Oct 2012
ESCALATE LAMINOPLASTY SYSTEM
K113802 · Stryker Spine · Apr 2012
MOUNTAINEER LAMINOPLASTY SYSTEM
K091994 · Depuy Spine, Inc. · Jan 2010