Cleared Traditional

K043020 - GLAXY 3.2 SPINAL SYSTEM

K043020 is an FDA 510(k) clearance for GLAXY 3.2 SPINAL SYSTEM, manufactured by Medtronic Sofamor Danek. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K043020 · Medtronic Sofamor Danek · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
65d
Days
Class 2
Risk

K043020 is an FDA 510(k) clearance for the GLAXY 3.2 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 January 7, 2005 after a review of 65 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. 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 Medtronic Sofamor Danek devices

FDA 510(k) Submission Details - K043020

510(k) Number K043020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2004
Decision Date January 07, 2005
Days to Decision 65 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
57d faster than avg
Panel avg: 122d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWP Device Classification - Class 2, Special Controls

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 382
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K043020.
ISSYS PEDICLE SCREW SYSTEM
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K043355 · Sintea Biotech, Inc. · Dec 2004