Cleared Special

K070995 - ARX-LINK CROSS CONNECTOR

K070995 is the FDA 510(k) clearance for ARX-LINK CROSS CONNECTOR by Life Spine. It is a Class 2 Orthopedic device (product code NKB) cleared through the Special 510(k) pathway after a 74-day FDA review.

K070995 · Life Spine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
74d
Days
Class 2
Risk

K070995 is an FDA 510(k) clearance for the ARX-LINK CROSS CONNECTOR. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Life Spine (Hoffman Estates, US). The FDA issued a Cleared decision on June 22, 2007 after a review of 74 days - a notably fast clearance 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Life Spine devices

Submission Details

510(k) Number K070995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2007
Decision Date June 22, 2007
Days to Decision 74 days
Submission Type Special
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
48d faster than avg
Panel avg: 122d · This submission: 74d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 649
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K070995.
EXPEDIUM SPINE SYSTEM
K063772 · Depuy Spine, Inc. · Jul 2007
QUANTUM SPINAL SYSTEM
K070973 · Pioneer Surgical Technology · Jul 2007
MODIFICATIONS TO CD HORIZON SPINAL SYSTEM
K063670 · Medtronic Sofamor Danek · Jun 2007
TRIO PLATE SYSTEM, TRIO SPINAL FIXATION SYSTEM, TRIO+ SPINAL SYSTEM
K070368 · Stryker Corp. · May 2007
MODIFICATION TO: PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM
K070551 · Pioneer Surgical Technology · Mar 2007
MODIFICATION TO S4 SPINAL SYSTEM
K062327 · Aesculap, Inc. · Mar 2007