Cleared Traditional

K073143 - MODIFIED VERTIFLEX SPINAL SCREW SYSTEM

K073143 is an FDA 510(k) clearance for MODIFIED VERTIFLEX SPINAL SCREW SYSTEM, manufactured by Vertiflex, Inc.. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K073143 · Vertiflex, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
152d
Days
Class 2
Risk

K073143 is an FDA 510(k) clearance for the MODIFIED VERTIFLEX SPINAL SCREW SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Vertiflex, Inc. (San Clamente, US). The FDA issued a Cleared decision on April 7, 2008 after a review of 152 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. 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 Vertiflex, Inc. devices

FDA 510(k) Submission Details - K073143

510(k) Number K073143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2007
Decision Date April 07, 2008
Days to Decision 152 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
30d slower than avg
Panel avg: 122d · This submission: 152d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNI Device Classification - Class 2, Special Controls

Product Code MNI Orthosis, Spinal Pedicle Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNI Orthosis, Spinal Pedicle Fixation

All 199
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K073143.
CAPSURE PS (R) SPINE SYSTEM
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K2M COCR ROD
K080792 · K2m, Inc. · Apr 2008
PSS SYSTEM
K073240 · Spinal USA · Mar 2008
BLACKSTONE SFS PARALLEL ROD CONNECTORS
K080407 · Blackstone Medical, Inc. · Mar 2008
MODIFICATION TO STRYKER SPINE OASYS SYSTEM
K080143 · Stryker Spine · Feb 2008