Cleared Traditional

K073562 - MODIFICATION TO VIPER SPINE SYSTEM

K073562 is the FDA 510(k) clearance for MODIFICATION TO VIPER SPINE SYSTEM by Depuy Spine, Inc.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K073562 · Depuy Spine, Inc. · Orthopedic device
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May 2008
Decision
148d
Days
Class 2
Risk

K073562 is an FDA 510(k) clearance for the MODIFICATION TO VIPER SPINE SYSTEM. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Depuy Spine, Inc. (Raynham, US). The FDA issued a Cleared decision on May 15, 2008 after a review of 148 days - within the typical 510(k) review window.

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 Depuy Spine, Inc. devices

Submission Details

510(k) Number K073562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2007
Decision Date May 15, 2008
Days to Decision 148 days
Submission Type Traditional
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
26d slower than avg
Panel avg: 122d · This submission: 148d
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 614
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K073562.
AXIS FIXATION SYSTEM
K062254 · Medtronic Sofamor Danek, Inc. · Jun 2008
EXPEDIUM 4.5MM SPINE SYSTEM
K081252 · Depuy Spine, Inc. · May 2008
REVERE UNIPLANAR SCREWS
K081195 · Globus Medical, Inc. · May 2008
MODIFICATION TO EXPEDIUM SPINE SYSTEM
K080313 · Depuy Spine, Inc. · May 2008
XIA SPINAL SYSTEM, STAINLESS STEEL UNI-PLANAR SCREWS
K080928 · Stryker Spine · Apr 2008
EXPEDIUM 4.5MM SPINE SYSTEM
K073364 · Depuy Spine, Inc. · Apr 2008