Cleared Traditional

K073430 - VALEO PEDICLE SCREW SPINAL SYSTEM

K073430 is the FDA 510(k) clearance for VALEO PEDICLE SCREW SPINAL SYSTEM by Amedica Corp.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K073430 · Amedica Corp. · Orthopedic device
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Jan 2008
Decision
54d
Days
Class 2
Risk

K073430 is an FDA 510(k) clearance for the VALEO PEDICLE SCREW SPINAL SYSTEM. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Amedica Corp. (Washington, US). The FDA issued a Cleared decision on January 29, 2008 after a review of 54 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Amedica Corp. devices

Submission Details

510(k) Number K073430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2007
Decision Date January 29, 2008
Days to Decision 54 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
68d faster than avg
Panel avg: 122d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 662
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K073430.
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