Cleared Traditional

K070460 - ALLEZ SPINE CROSS CONNECTORS

K070460 is an FDA 510(k) clearance for ALLEZ SPINE CROSS CONNECTORS, manufactured by Allez Spine, LLC. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K070460 · Allez Spine, LLC · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jun 2007
Decision
115d
Days
Class 2
Risk

K070460 is an FDA 510(k) clearance for the ALLEZ SPINE CROSS CONNECTORS. 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 June 11, 2007 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 Allez Spine, LLC devices

FDA 510(k) Submission Details - K070460

510(k) Number K070460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2007
Decision Date June 11, 2007
Days to Decision 115 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
7d faster than avg
Panel avg: 122d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K070460.
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MODIFICATIONS TO CD HORIZON SPINAL SYSTEM
K063670 · Medtronic Sofamor Danek · Jun 2007
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K070995 · Life Spine · Jun 2007
TRIO PLATE SYSTEM, TRIO SPINAL FIXATION SYSTEM, TRIO+ SPINAL SYSTEM
K070368 · Stryker Corp. · May 2007
ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM
K070367 · Endius, Inc. · Apr 2007
MODIFICATION TO: PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM
K070551 · Pioneer Surgical Technology · Mar 2007