Cleared Traditional

K073278 - SPINOUS PROCESS PLATE SYSTEM

K073278 is an FDA 510(k) clearance for SPINOUS PROCESS PLATE SYSTEM, manufactured by Nuvasive, Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K073278 · Nuvasive, Inc. · Orthopedic device
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Mar 2008
Decision
128d
Days
Class 2
Risk

K073278 is an FDA 510(k) clearance for the SPINOUS PROCESS PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Nuvasive, Inc. (San Diego, US). The FDA issued a Cleared decision on March 28, 2008 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 Nuvasive, Inc. devices

FDA 510(k) Submission Details - K073278

510(k) Number K073278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2007
Decision Date March 28, 2008
Days to Decision 128 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
6d slower than avg
Panel avg: 122d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 388
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