Cleared Special

K992928 - CD HORIZON SPINAL SYSTEM

K992928 is an FDA 510(k) clearance for CD HORIZON SPINAL SYSTEM, manufactured by Sofamor Danek USA,Inc.. The device is a Class 2 Orthopedic device with product code MNI cleared through the Special 510(k) pathway after a 21-day FDA review.

K992928 · Sofamor Danek USA,Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
21d
Days
Class 2
Risk

K992928 is an FDA 510(k) clearance for the CD HORIZON SPINAL SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Sofamor Danek USA,Inc. (Memphis, US). The FDA issued a Cleared decision on September 21, 1999 after a review of 21 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 Sofamor Danek USA,Inc. devices

FDA 510(k) Submission Details - K992928

510(k) Number K992928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1999
Decision Date September 21, 1999
Days to Decision 21 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
101d faster than avg
Panel avg: 122d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

MNI Device Classification - Class 2, Special Controls

Product Code MNI Orthosis, Spinal Pedicle 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 - MNI Orthosis, Spinal Pedicle Fixation

All 184
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K992928.
ISOBAR SPINAL SYSTEM
K992738 · Encore Orthopedics, Inc. · Nov 1999
SYNERGY INTEGRAL SCREWS, MODELS, 2161,2162,2163,2164,2165,2166,2167,2168,2169,2210,2211,2212,2215,2216,2217,2220,2221,22
K992369 · Interpore Cross Intl. · Oct 1999
EBI OMEGA 21 SYSTEM
K992333 · Electro-Biology, Inc. · Oct 1999
SYNERGY ADJUSTABLE LENGTH ROD
K990057 · Interpore Cross Intl. · Jun 1999
MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEM
K990745 · Synthes Spine · Mar 1999
SYNERGY D2 SPINAL IMPLANTS
K984578 · Interpore Cross Intl. · Mar 1999