Cleared Traditional

K033926 - HOURGLASS VERTEBRAL BODY SPACER

K033926 is an FDA 510(k) clearance for HOURGLASS VERTEBRAL BODY SPACER, manufactured by Medtronic Sofamor Danek. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K033926 · Medtronic Sofamor Danek · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jul 2004
Decision
202d
Days
Class 2
Risk

K033926 is an FDA 510(k) clearance for the HOURGLASS VERTEBRAL BODY SPACER. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on July 7, 2004 after a review of 202 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 Medtronic Sofamor Danek devices

FDA 510(k) Submission Details - K033926

510(k) Number K033926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2003
Decision Date July 07, 2004
Days to Decision 202 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
80d slower than avg
Panel avg: 122d · This submission: 202d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQP Device Classification - Class 2, Special Controls

Product Code MQP Spinal Vertebral Body Replacement Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - MQP Spinal Vertebral Body Replacement Device

All 259
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K033926.
CURVED PEEK TETRIS SPINAL IMPLANT
K041888 · Signus Medizintechnik GmbH · Aug 2004
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K041197 · Medtronic Sofamor Danek · Aug 2004
STRYKER SPINE VERTEBRAL SPACER
K040731 · Stryker Spine · Aug 2004
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K041556 · Medtronic Sofamor Danek · Jul 2004
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K041452 · Medtronic Sofamor Danek · Jun 2004
SPINAL CONCEPTS INC. CODA
K033663 · Spinal Concepts, Inc. · May 2004