Cleared Traditional

K083026 - CLYDESDALE SPINAL SYSTEM

K083026 is an FDA 510(k) clearance for CLYDESDALE SPINAL SYSTEM, manufactured by Medtronic Sofamor Danek. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K083026 · Medtronic Sofamor Danek · Orthopedic device
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Dec 2008
Decision
80d
Days
Class 2
Risk

K083026 is an FDA 510(k) clearance for the CLYDESDALE SPINAL SYSTEM. Classified as Intervertebral Fusion Device With Bone Graft, Lumbar within the MAX classification (a category for intervertebral fusion devices and spinal implants), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on December 29, 2008 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - 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 - K083026

510(k) Number K083026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2008
Decision Date December 29, 2008
Days to Decision 80 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
42d faster than avg
Panel avg: 122d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MAX Device Classification - Class 2, Special Controls

Product Code MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.
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 - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 849
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K083026.
LDR SPINE ROI INTERBODY FUSION SYSTEM
K082262 · Ldr Spine USA · Feb 2009
EXPANDABLE PEEK-OPTIMA IMPLANT
K082406 · Ebi, L.P. · Jan 2009
THEKEN SPINE VU EPOD AND VU LPOD SYSTEM
K082712 · Theken Spine, LLC · Jan 2009
HOLLYWOOD, PACIFICA, REDONDO, VENTURA
K082310 · Seaspine, Inc. · Nov 2008
SPINAL USA VBR SYSTEM
K081196 · Spinal USA · Oct 2008
MODIFICATION TO: CAPSTONE SPINAL SYSTEM
K082732 · Medtronic Sofamor Danek USA, Inc. · Oct 2008