Cleared Traditional

K993066 - WINDOW CERVICAL DYNAMIC PLATE SYSTEM

K993066 is an FDA 510(k) clearance for WINDOW CERVICAL DYNAMIC PLATE SYSTEM, manufactured by Advanced Spine Technology, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 349-day FDA review.

K993066 · Advanced Spine Technology, Inc. · Orthopedic device
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Jun 2000
Decision
349d
Days
Class 2
Risk

K993066 is an FDA 510(k) clearance for the WINDOW CERVICAL DYNAMIC PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Advanced Spine Technology, Inc. (Oakland, US). The FDA issued a Cleared decision on June 7, 2000 after a review of 349 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Advanced Spine Technology, Inc. devices

FDA 510(k) Submission Details - K993066

510(k) Number K993066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1999
Decision Date June 07, 2000
Days to Decision 349 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
227d slower than avg
Panel avg: 122d · This submission: 349d
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 527
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K993066.
MODIFICATION TO CENTAUR SPINAL SYSTEM
K001844 · Howmedica Osteonics Corp. · Jul 2000
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
DELTALOC ANTERIOR CERVICAL PLATE SYSTEM
K993513 · Alphatec Mfg., Inc. · Apr 2000
ABC CERVICAL PLATING SYSTEM
K000486 · Aesculap, Inc. · Apr 2000