Cleared Special

K072678 - LAGUNA SIZE 8 PEDICLE SCREW

K072678 is an FDA 510(k) clearance for LAGUNA SIZE 8 PEDICLE SCREW, manufactured by Allez Spine, LLC. The device is a Class 2 Orthopedic device with product code NKB cleared through the Special 510(k) pathway after a 285-day FDA review.

K072678 · Allez Spine, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
285d
Days
Class 2
Risk

K072678 is an FDA 510(k) clearance for the LAGUNA SIZE 8 PEDICLE SCREW. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Allez Spine, LLC (Irvine, US). The FDA issued a Cleared decision on July 2, 2008 after a review of 285 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Allez Spine, LLC devices

FDA 510(k) Submission Details - K072678

510(k) Number K072678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2007
Decision Date July 02, 2008
Days to Decision 285 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
163d slower than avg
Panel avg: 122d · This submission: 285d
Pathway characteristics
Modification to existing cleared device.

NKB Device Classification - Class 2, Special Controls

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.
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 - NKB Thoracolumbosacral Pedicle Screw System

All 751
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K072678.
BLACKSTONE PEDICLE SCREW SYSTEM
K081684 · Blackstone Medical, Inc. · Sep 2008
EXPEDIUM SPINE SYSTEM
K081898 · Depuy Spine, Inc. · Sep 2008
MODIFICATIONS TO EXPEDIUM SPINE SYSTEM
K082195 · Depuy Spine, Inc. · Sep 2008
MODIFICATION TO CORAL SPINAL SYSTEM
K081414 · Theken Spine, LLC · Jun 2008
AXIS FIXATION SYSTEM
K062254 · Medtronic Sofamor Danek, Inc. · Jun 2008
EXPEDIUM 4.5MM SPINE SYSTEM
K081252 · Depuy Spine, Inc. · May 2008