Cleared Traditional

K073502 - VERTEBRON VBR SYSTEM

K073502 is an FDA 510(k) clearance for VERTEBRON VBR SYSTEM, manufactured by Vertebron, Inc.. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K073502 · Vertebron, Inc. · Orthopedic device
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Mar 2008
Decision
102d
Days
Class 2
Risk

K073502 is an FDA 510(k) clearance for the VERTEBRON VBR SYSTEM. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Vertebron, Inc. (Stratford, US). The FDA issued a Cleared decision on March 24, 2008 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 Vertebron, Inc. devices

FDA 510(k) Submission Details - K073502

510(k) Number K073502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2007
Decision Date March 24, 2008
Days to Decision 102 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
20d faster than avg
Panel avg: 122d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQP Device Classification - Class 2, Special Controls

Product Code MQP Spinal Vertebral Body Replacement Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - MQP Spinal Vertebral Body Replacement Device

All 213
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K073502.
LDR SPINE ROI-T IMPLANT
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LDR SPINE ROI-A IMPLANT
K080572 · Ldr Spine USA · Apr 2008
KIMBA MINI
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BENGAL STACKABLE CAGE SYSTEM
K073649 · Depuy Spine, Inc. · Jan 2008
ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01
K080024 · K2m, Inc. · Jan 2008