Cleared Special

K001532 - DYNA-LOK CLASSIC SPINAL SYSTEM

K001532 is the FDA 510(k) clearance for DYNA-LOK CLASSIC SPINAL SYSTEM by Medtronic Sofamor Danek, Inc.. It is a Class 2 Orthopedic device (product code KWP) cleared through the Special 510(k) pathway after a 30-day FDA review.

K001532 · Medtronic Sofamor Danek, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
30d
Days
Class 2
Risk

K001532 is an FDA 510(k) clearance for the DYNA-LOK CLASSIC SPINAL SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek, Inc. (Memphis, US). The FDA issued a Cleared decision on June 16, 2000 after a review of 30 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, Inc. devices

Submission Details

510(k) Number K001532 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2000
Decision Date June 16, 2000
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
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 266
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K001532.
E-Z LINK CROSS CONNECTOR
K001470 · Depuyacromed · Aug 2000
E-Z LINK CROSS CONNECTOR
K001372 · Depuyacromed · Jul 2000
SPINE SYSTEM EVOLUTION
K001080 · Aesculap, Inc. · Jun 2000
MOSS MIAMI 6.35MM ROD SYSTEM PEDICLE AND LAMINAR HOOKS
K001105 · Depuyacromed · Apr 2000
SYNTHES CERVIFIX SYSTEM
K994187 · Synthes (Usa) · Dec 1999
CONTOUR SPINAL SYSTEM
K990986 · Ortho Development Corp. · Oct 1999