Cleared Special

K023415 - MODIFICATION TO DYNALOK CLASSIC SPINAL ...

K023415 is the FDA 510(k) clearance for MODIFICATION TO DYNALOK CLASSIC SPINAL ... by Medtronic Sofamor Danek. It is a Class 2 Orthopedic device (product code KWP) cleared through the Special 510(k) pathway after a 63-day FDA review.

K023415 · Medtronic Sofamor Danek · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
63d
Days
Class 2
Risk

K023415 is an FDA 510(k) clearance for the MODIFICATION TO DYNALOK CLASSIC SPINAL SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on December 13, 2002 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 Medtronic Sofamor Danek devices

Submission Details

510(k) Number K023415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2002
Decision Date December 13, 2002
Days to Decision 63 days
Submission Type Special
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
59d faster than avg
Panel avg: 122d · This submission: 63d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 271
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K023415.
MODIFICATION TO XIA STAINLESS STEEL SYSTEM
K031090 · Howmedica Osteonics Corp. · Apr 2003
MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM
K030241 · Blackstone Medical, Inc. · Feb 2003
MOSS MIAMI SPINAL SYSTEM PIN NUT
K023804 · Depuyacromed · Jan 2003
LAURAIN DEWALD ANTERIOR FIXATION SYSTEM
K023797 · Medtronic Sofamor Danek · Dec 2002
CD HORIZON SPINAL SYSTEM
K014296 · Medtronic Sofamor Danek · Dec 2002
INTERPORE CROSS INTERNATIONAL (ICI) OCCIPITO-CERVICO-THORACIC (OCT) ROD AND PLATE SYSTEM
K022048 · Interpore Cross Intl. · Dec 2002