Cleared Traditional

K000486 - ABC CERVICAL PLATING SYSTEM

K000486 is the FDA 510(k) clearance for ABC CERVICAL PLATING SYSTEM by Aesculap, Inc.. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K000486 · Aesculap, Inc. · Orthopedic device
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Apr 2000
Decision
60d
Days
Class 2
Risk

K000486 is an FDA 510(k) clearance for the ABC CERVICAL PLATING SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Aesculap, Inc. (South San Francisco, US). The FDA issued a Cleared decision on April 14, 2000 after a review of 60 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Aesculap, Inc. devices

Submission Details

510(k) Number K000486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2000
Decision Date April 14, 2000
Days to Decision 60 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
62d faster than avg
Panel avg: 122d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 448
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K000486.
EBI ANTERIOR CERVICAL PLATE SYSTEM
K001794 · Ebi, L.P. · Jul 2000
ZEPHIR ANTERIOR CERVICAL PLATE SYSTEM
K994239 · Medtronic Sofamor Danek, Inc. · Jun 2000
XIA SPINE SYSTEM
K001272 · Howmedica Osteonics Corp. · May 2000
SYNTHES ANTERIOR CSLP SYSTEM
K000742 · Synthes Spine · Mar 2000
SYNTHES ANTERIOR CSLP SYSTEM
K000536 · Synthes Spine · Mar 2000
CENTAUR SPINAL SYSTEM
K994347 · Howmedica Osteonics Corp. · Mar 2000