Cleared Special

K091044 - SPINAL USA ANTERIOR LUMBAR PLATE SYSTEM

K091044 is an FDA 510(k) clearance for SPINAL USA ANTERIOR LUMBAR PLATE SYSTEM, manufactured by Spinal USA. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Special 510(k) pathway after a 87-day FDA review.

K091044 · Spinal USA · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
87d
Days
Class 2
Risk

K091044 is an FDA 510(k) clearance for the SPINAL USA ANTERIOR LUMBAR PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Spinal USA (Pear, US). The FDA issued a Cleared decision on July 9, 2009 after a review of 87 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Spinal USA devices

FDA 510(k) Submission Details - K091044

510(k) Number K091044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2009
Decision Date July 09, 2009
Days to Decision 87 days
Submission Type Special
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
35d faster than avg
Panel avg: 122d · This submission: 87d
Pathway characteristics
Modification to existing cleared device.

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 470
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K091044.
XTEND ANTERIOR CERVICAL PLATE SYSTEM
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THORACOLUMBAR PLATE, MODEL 1208-41FXX, LUMBER PLATE, MODEL 1208-41FXXL, SACRAL PLATE, MODEL 1208-41FXXS
K091253 · K2m, Inc. · Jun 2009
NUVASIVE LATERAL PLATE SYSTEM
K091071 · Nuvasive, Inc. · May 2009
PIONEER LUMBAR PLATE SYSTEM
K090222 · Pioneer Surgical Technology · Apr 2009