Cleared Traditional

K964623 - TITANIUM CD HORIZON ANTERIOR SPINAL SYSTEM

K964623 is an FDA 510(k) clearance for TITANIUM CD HORIZON ANTERIOR SPINAL SYSTEM, manufactured by Sofamor Danek USA,Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K964623 · Sofamor Danek USA,Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Feb 1997
Decision
80d
Days
Class 2
Risk

K964623 is an FDA 510(k) clearance for the TITANIUM CD HORIZON ANTERIOR SPINAL SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Sofamor Danek USA,Inc. (Memphis, US). The FDA issued a Cleared decision on February 6, 1997 after a review of 80 days - a notably fast clearance cycle.

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

FDA 510(k) Submission Details - K964623

510(k) Number K964623 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 18, 1996
Decision Date February 06, 1997
Days to Decision 80 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
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.

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 470
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K964623.
SYNTHES (U.S.A.)UNIVERSAL SPINAL PARELLEL CONNECTOR THE UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM
K964416 · Synthes (Usa) · Mar 1997
LIBERTY ANTERIOR SPINAL SYSTEM
K965193 · Sofamor Danek USA,Inc. · Mar 1997
ANTERIOR DYNAMIZED SYSTEM
K953978 · Acromed Corp. · Feb 1997
DEPUY MOTECH ANTERIOR COMPRESSION PLATE SYSTEM
K962486 · Depuy, Inc. · Dec 1996
CD HORIZON ANTERIOR SPINAL SYSTEM
K963655 · Sofamor Danek USA,Inc. · Nov 1996
EBI ANTERIOR CERVICAL SPINE SYSTEM
K955730 · Electro-Biology, Inc. · Mar 1996