Cleared Traditional

K072703 - PIONEER SLIMFUSE ANTERIOR CERVICAL PLAT...

K072703 is the FDA 510(k) clearance for PIONEER SLIMFUSE ANTERIOR CERVICAL PLAT... by Pioneer Surgical Technology. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K072703 · Pioneer Surgical Technology · Orthopedic device
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Jan 2008
Decision
108d
Days
Class 2
Risk

K072703 is an FDA 510(k) clearance for the PIONEER SLIMFUSE ANTERIOR CERVICAL PLATING SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Pioneer Surgical Technology (Marquette, US). The FDA issued a Cleared decision on January 10, 2008 after a review of 108 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 Pioneer Surgical Technology devices

Submission Details

510(k) Number K072703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2007
Decision Date January 10, 2008
Days to Decision 108 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
14d faster than avg
Panel avg: 122d · This submission: 108d
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 438
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