Cleared Special

K993810 - CD HORIZON SPINAL SYSTEM

K993810 is an FDA 510(k) clearance for CD HORIZON SPINAL SYSTEM, manufactured by Danek Medical, Inc.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Special 510(k) pathway after a 85-day FDA review.

K993810 · Danek Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
85d
Days
Class 2
Risk

K993810 is an FDA 510(k) clearance for the CD HORIZON SPINAL SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Danek Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on February 3, 2000 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 - K993810

510(k) Number K993810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 1999
Decision Date February 03, 2000
Days to Decision 85 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
37d faster than avg
Panel avg: 122d · This submission: 85d
Pathway characteristics
Modification to existing cleared device.

MNH Device Classification - Class 2, Special Controls

Product Code MNH Orthosis, Spondylolisthesis Spinal Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 170
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K993810.
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K000094 · Medtronic Sofamor Danek USA, Inc. · Feb 2000
CLICK'X
K992739 · Synthes Spine · Feb 2000
MODIFICATION TO ISOBAR SPINAL SYSTEM
K000020 · Encore Orthopedics, Inc. · Feb 2000
SOCON SPINAL SYSTEM
K993551 · Aesculap, Inc. · Jan 2000
SYNERGY INTEGRAL SCREWS, MODEL NUMBERS 2161,2162,2163,2164,2165,2166,2167,2168,2169,2210,2211,2212,2215,2216,2217,2220
K993808 · Interpore Cross Intl. · Dec 1999
DANEK PLATE AND SCREW SYSTEM
K991036 · Sofamor Danek USA,Inc. · Sep 1999