Cleared Traditional

K022997 - SPECTRUM CERVICAL SPINAL SYSTEM

K022997 is an FDA 510(k) clearance for SPECTRUM CERVICAL SPINAL SYSTEM, manufactured by Spinal Innovations, LLC. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K022997 · Spinal Innovations, LLC · Orthopedic device
Download Printable Device Report (PDF)
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Dec 2002
Decision
88d
Days
Class 2
Risk

K022997 is an FDA 510(k) clearance for the SPECTRUM CERVICAL SPINAL SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Spinal Innovations, LLC (Bartlett, US). The FDA issued a Cleared decision on December 6, 2002 after a review of 88 days - a notably fast clearance 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: 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 Spinal Innovations, LLC devices

FDA 510(k) Submission Details - K022997

510(k) Number K022997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2002
Decision Date December 06, 2002
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWQ Device Classification - Class 2, Special Controls

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 558
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K022997.
ZEPHIR ANTERIOR CERVICAL SYSTEM
K030327 · Medtronic Sofamor Danek · Feb 2003
SPINAL CONCEPTS, INC. ANT-CER DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM
K024326 · Spinal Concepts, Inc. · Jan 2003
BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM
K021039 · Depuyacromed · Dec 2002
CERVIVE ANTERIOR CERVICAL PLATING SYSTEM, MODEL NUMBER 157.XXX SERIES CATALOGUE NUMBERS
K022798 · Corin USA · Nov 2002
SYNTHES ANTERIOR TENSION BAND (ATB) SYSTEM
K022791 · Synthes (Usa) · Nov 2002
INCOMPASS SPINAL FIXATION SYSTEM
K021564 · Spinal Concepts, Inc. · Oct 2002