Cleared Special

K990603 - MODIFICATION OF THE ZPLATE-ATL ANTERIOR...

K990603 is an FDA 510(k) clearance for MODIFICATION OF THE ZPLATE-ATL ANTERIOR..., manufactured by Danek Medical, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Special 510(k) pathway after a 15-day FDA review.

K990603 · Danek Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
15d
Days
Class 2
Risk

K990603 is an FDA 510(k) clearance for the MODIFICATION OF THE ZPLATE-ATL ANTERIOR FIXATION SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Danek Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on March 10, 1999 after a review of 15 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. 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.

View all Danek Medical, Inc. devices

FDA 510(k) Submission Details - K990603

510(k) Number K990603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1999
Decision Date March 10, 1999
Days to Decision 15 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
107d faster than avg
Panel avg: 122d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

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 K990603.
OSTEONICS ACCP SYSTEM LINE EXTENSION
K992344 · Howmedica Osteonics Corp. · Jul 1999
EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM
K991092 · Electro-Biology, Inc. · Apr 1999
OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM
K982798 · Osteonics Corp. · Mar 1999
XIA SPINE SYSTEM
K984251 · Howmedica, Inc. · Feb 1999
SPINAL CONCEPTS, INC. (SCI) ANTERIOR CERVICAL PLATE SYSTEM
K990005 · Spinal Concepts, Inc. · Feb 1999
MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM
K982875 · Danek Medical, Inc. · Jan 1999