Cleared Traditional

K981676 - CD HORIZON SPINAL SYSTEM

K981676 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 KWP cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K981676 · Sofamor Danek USA,Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1999
Decision
261d
Days
Class 2
Risk

K981676 is an FDA 510(k) clearance for the CD HORIZON SPINAL SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Sofamor Danek USA,Inc. (Memphis, US). The FDA issued a Cleared decision on January 28, 1999 after a review of 261 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Sofamor Danek USA,Inc. devices

FDA 510(k) Submission Details - K981676

510(k) Number K981676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1998
Decision Date January 28, 1999
Days to Decision 261 days
Submission Type Traditional
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
139d slower than avg
Panel avg: 122d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 309
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K981676.
OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY
K984375 · Osteonics Corp. · Apr 1999
EBI OMEGA 21 SYSTEM
K990303 · Electro-Biology, Inc. · Apr 1999
TITANIUM VERSALOK
K990708 · Wrightmedicaltechnologyinc · Mar 1999
SYNTHES SPINE CERVIFIX SYSTEM
K984377 · Synthes (Usa) · Jan 1999
ROGOZINSKI SPINAL ROD SYSTEM
K983904 · United States Surgical, A Division of Tyco Healthc · Dec 1998
SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM
K983530 · Synthes (Usa) · Dec 1998