Cleared Traditional

K233360 - Curiteva Thoracolumbar Plate System

K233360 is an FDA 510(k) clearance for Curiteva Thoracolumbar Plate System, manufactured by Curiteva, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K233360 · Curiteva, Inc. · Orthopedic device
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Feb 2024
Decision
153d
Days
Class 2
Risk

K233360 is an FDA 510(k) clearance for the Curiteva Thoracolumbar Plate System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Curiteva, Inc. (Tanner, US). The FDA issued a Cleared decision on February 29, 2024 after a review of 153 days - an extended review 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: 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 Curiteva, Inc. devices

FDA 510(k) Submission Details - K233360

510(k) Number K233360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2023
Decision Date February 29, 2024
Days to Decision 153 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
31d slower than avg
Panel avg: 122d · This submission: 153d
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 470
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K233360.
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K240515 · Ulrich Medical USA, Inc. · Mar 2024
Segmental Plating System (SPS)
K233640 · Alphatec Spine, Inc. · Feb 2024
MONDRIAN™ Anterior Lumbar Plate System
K231715 · Ctl Medical Corporation · Jan 2024
ADIRA™ Lateral Plate System
K233735 · Globus Medical, Inc. · Jan 2024