Cleared Special

K073245 - EXTENDED VERTIFLEX SPINAL SCREW SYSTEM

K073245 is an FDA 510(k) clearance for EXTENDED VERTIFLEX SPINAL SCREW SYSTEM, manufactured by Vertiflex, Inc.. The device is a Class 2 Orthopedic device with product code NKB cleared through the Special 510(k) pathway after a 88-day FDA review.

K073245 · Vertiflex, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
88d
Days
Class 2
Risk

K073245 is an FDA 510(k) clearance for the EXTENDED VERTIFLEX SPINAL SCREW SYSTEM. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Vertiflex, Inc. (San Clamente, US). The FDA issued a Cleared decision on February 15, 2008 after a review of 88 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 Vertiflex, Inc. devices

FDA 510(k) Submission Details - K073245

510(k) Number K073245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2007
Decision Date February 15, 2008
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
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 733
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K073245.
PIONEER LOWTOP SPINAL ROD SYSTEM
K080504 · Pioneer Surgical Technology · Mar 2008
PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM
K080518 · Pioneer Surgical Technology · Mar 2008
MODIFICATION TO ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
K080258 · Endius, Inc. · Mar 2008
ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM
K073510 · Endius, Inc. · Feb 2008
ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
K073267 · Endius, Inc. · Jan 2008
LIFE SPINE CROSS CONNECTOR
K073480 · Life Spine · Jan 2008