Cleared Traditional

K073530 - ACCIN ANTERIOR CERVICAL PLATE SYSTEM

K073530 is an FDA 510(k) clearance for ACCIN ANTERIOR CERVICAL PLATE SYSTEM, manufactured by Accelerated Innovation, LLC. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K073530 · Accelerated Innovation, LLC · Orthopedic device
Download Printable Device Report (PDF)
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Jan 2008
Decision
45d
Days
Class 2
Risk

K073530 is an FDA 510(k) clearance for the ACCIN ANTERIOR CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Accelerated Innovation, LLC (Clifton, US). The FDA issued a Cleared decision on January 31, 2008 after a review of 45 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 Accelerated Innovation, LLC devices

FDA 510(k) Submission Details - K073530

510(k) Number K073530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2007
Decision Date January 31, 2008
Days to Decision 45 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
77d faster than avg
Panel avg: 122d · This submission: 45d
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 511
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K073530.
INDUS ANTERIOR CERVICAL PLATE SYSTEM, MODEL IM3XXX
K073232 · Spinefrontier, Inc. · Feb 2008
RELIANCE BUTTRESS WASHER SYSTEM
K073349 · Reliance Medical Systems, LLC · Feb 2008
THOR ANTERIOR PLATING SYSTEM
K073437 · Stryker Spine · Feb 2008
NUVASIVE HELIX MINI ACP SYSTEM
K073275 · Nuvasive, Inc. · Jan 2008
BUTREX BUTTRESS PLATING SYSTEM
K072943 · X-Spine Systems, Inc. · Jan 2008
PIONEER SLIMFUSE ANTERIOR CERVICAL PLATING SYSTEM
K072703 · Pioneer Surgical Technology · Jan 2008