Cleared Traditional

K061002 - MAXIMA ANTERIOR CERVICAL PLATE SYSTEM

K061002 is an FDA 510(k) clearance for MAXIMA ANTERIOR CERVICAL PLATE SYSTEM, manufactured by U&I Corp.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K061002 · U&I Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
218d
Days
Class 2
Risk

K061002 is an FDA 510(k) clearance for the MAXIMA ANTERIOR CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by U&I Corp. (Uijungbu, Gyeonggi-Do, KR). The FDA issued a Cleared decision on November 15, 2006 after a review of 218 days - an extended review cycle.

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 U&I Corp. devices

FDA 510(k) Submission Details - K061002

510(k) Number K061002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2006
Decision Date November 15, 2006
Days to Decision 218 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
96d slower than avg
Panel avg: 122d · This submission: 218d
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 491
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K061002.
NUVASIVE ACP4 SYSTEM
K062590 · Nuvasive, Inc. · Jan 2007
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K062836 · Globus Medical, Inc. · Dec 2006
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K062643 · Life Spine · Nov 2006
SYNTHES ANTEGRA SYSTEM
K063158 · Synthes Spine Co.Lp · Nov 2006
MODIFICATION TO LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM
K062831 · Life Spine · Oct 2006
GATEWAY THORACOLUMBAR PLATE SYSTEM
K062407 · Globus Medical, Inc. · Sep 2006