Cleared Traditional

K001668 - GLOBAL SPINAL FIXATION SYSTEM

K001668 is an FDA 510(k) clearance for GLOBAL SPINAL FIXATION SYSTEM, manufactured by D.K.M. Co., Ltd.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K001668 · D.K.M. Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
141d
Days
Class 2
Risk

K001668 is an FDA 510(k) clearance for the GLOBAL SPINAL FIXATION SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by D.K.M. Co., Ltd. (St. Louis, US). The FDA issued a Cleared decision on October 19, 2000 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 D.K.M. Co., Ltd. devices

FDA 510(k) Submission Details - K001668

510(k) Number K001668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2000
Decision Date October 19, 2000
Days to Decision 141 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 122d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 248
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K001668.
CD HORIZON SPINAL SYSTEM
K000641 · Medtronic Sofamor Danek, Inc. · Dec 2000
OPUS ROD FIXATION SYSTEM
K003490 · Howmedica Osteonics Corp. · Dec 2000
VERSALINK TITANIUM ROD-TO-ROD COUPLERS
K003384 · Osteotech, Inc. · Nov 2000
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K002399 · Medtronic Sofamor Danek, Inc. · Sep 2000
CD HORIZON SPINAL SYSTEM
K001255 · Medtronic Sofamor Danek, Inc. · Jul 2000
CD HORIZON ECLIPSE
K001066 · Medtronic Sofamor Danek, Inc. · Jun 2000