Cleared Traditional

SPINAL CONCEPTS INC. CODA (K033663) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K033663 · Spinal Concepts, Inc. · Orthopedic device
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May 2004
Decision
188d
Days
Class 2
Risk

K033663 is an FDA 510(k) clearance for the SPINAL CONCEPTS INC. CODA. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Spinal Concepts, Inc. (Austin, US). The FDA issued a Cleared decision on May 27, 2004 after a review of 188 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 Spinal Concepts, Inc. devices

Submission Details

510(k) Number K033663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2003
Decision Date May 27, 2004
Days to Decision 188 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 122d · This submission: 188d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 68
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K033663.
HOURGLASS VERTEBRAL BODY SPACER
K033926 · Medtronic Sofamor Danek · Jul 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
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K040536 · Medtronic Sofamor Danek · May 2004
SUSTAIN RADIOLUCENT SPACER
K040284 · Globus Medical, Inc. · Mar 2004
MODIFICATION TO VERTE-STACK
K040422 · Medtronic Sofamor Danek · Mar 2004