Cleared Special

K993855 - ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

K993855 is an FDA 510(k) clearance for ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM, 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 30-day FDA review.

K993855 · Danek Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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Dec 1999
Decision
30d
Days
Class 2
Risk

K993855 is an FDA 510(k) clearance for the ATLANTIS ANTERIOR CERVICAL PLATE 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 December 15, 1999 after a review of 30 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 - K993855

510(k) Number K993855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1999
Decision Date December 15, 1999
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
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 K993855.
BONE GRAFT WASHER, MODEL 9090114 - 9090118
K994122 · Danek Medical, Inc. · Feb 2000
MODIFICATION TO ISOLA SPINAL SYSTEM
K993030 · Depuyacromed · Dec 1999
K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM
K990959 · Spineology, Inc. · Dec 1999
EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM
K993822 · Ebi, L.P. · Dec 1999
XIA SPINAL SYSTEM C-C ADAPTOR
K992792 · Howmedica Osteonics Corp. · Nov 1999
NEXT GENERATION RODDING SYSTEM
K992784 · United States Surgical, A Division of Tyco Healthc · Oct 1999