Cleared Traditional

K121862 - REX ANTERIOR CERVICAL PLATE SYSTEM

K121862 is an FDA 510(k) clearance for REX ANTERIOR CERVICAL PLATE SYSTEM, manufactured by Dio Medical Co., Ltd.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K121862 · Dio Medical Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2012
Decision
127d
Days
Class 2
Risk

K121862 is an FDA 510(k) clearance for the REX ANTERIOR CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Dio Medical Co., Ltd. (Brea, US). The FDA issued a Cleared decision on October 31, 2012 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 Dio Medical Co., Ltd. devices

FDA 510(k) Submission Details - K121862

510(k) Number K121862 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2012
Decision Date October 31, 2012
Days to Decision 127 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
5d slower than avg
Panel avg: 122d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 487
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K121862.
ANODYNE ANTERIOR CERVICAL PLATE SYSTEM
K121514 · Corelink, LLC · Dec 2012
V2F ANTERIOR FIXATION SYSTEM
K122733 · Zimmer Spine, Inc. · Dec 2012
ZOU ANTERIOR LUMBAR PLATE SYSTEM
K121791 · Corelink, LLC · Nov 2012
NUVASIVE SAGE LATERAL PLATE SYSTEM
K121815 · Nuvasive, Inc. · Oct 2012
ARCHON ANTERIOR CERVICAL PLATE SYSTE,
K122910 · Nu Vasive, Incorporated · Oct 2012
QUINTEX CERVICAL PLATING SYSTEM
K121801 · Aesculap Implant Systems, LLC · Sep 2012