Cleared Special

K041203 - SUMMIT OCT SPINAL SYSTEM

K041203 is an FDA 510(k) clearance for SUMMIT OCT SPINAL SYSTEM, manufactured by Depuy Spine, Inc.. The device is a Class 2 Orthopedic device with product code MNI cleared through the Special 510(k) pathway after a 26-day FDA review.

K041203 · Depuy Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
26d
Days
Class 2
Risk

K041203 is an FDA 510(k) clearance for the SUMMIT OCT SPINAL SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Depuy Spine, Inc. (Raynham, US). The FDA issued a Cleared decision on June 2, 2004 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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.

FDA 510(k) Submission Details - K041203

510(k) Number K041203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2004
Decision Date June 02, 2004
Days to Decision 26 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
96d faster than avg
Panel avg: 122d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

MNI Device Classification - Class 2, Special Controls

Product Code MNI Orthosis, Spinal Pedicle Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNI Orthosis, Spinal Pedicle Fixation

All 302
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K041203.
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K041777 · Medtronic Sofamor Danek · Sep 2004
ORTHOPEDIC ALLIANCE SPINE SYSTEM
K033826 · Orthopedic Alliance, LLC · Jul 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K041030 · Medtronic Sofamor Danek · Jun 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K041118 · Medtronic Sofamor Danek · May 2004
MODIFICATION TO: CD HORIZON SPINAL SYSTEM
K040583 · Medtronic Sofamor Danek · Mar 2004
MODIFICATION TO ORIA TOP CLIP SYSTEM
K040346 · Ortho Tec, LLC · Mar 2004
K041203 · SUMMIT OCT SPINAL SYSTEM
Download PDF FDA Summary Depuy Spine, Inc.