Cleared Special

K200381 - Daytona Small Stature Spinal System

K200381 is the FDA 510(k) clearance for Daytona Small Stature Spinal System by SeaSpine Orthopedics Corporation. It is a Class 2 Orthopedic device (product code NKB) cleared through the Special 510(k) pathway after a 10-day FDA review.

K200381 · SeaSpine Orthopedics Corporation · Orthopedic device
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Feb 2020
Decision
10d
Days
Class 2
Risk

K200381 is an FDA 510(k) clearance for the Daytona® Small Stature Spinal System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by SeaSpine Orthopedics Corporation (Carlsbad, US). The FDA issued a Cleared decision on February 28, 2020 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 SeaSpine Orthopedics Corporation devices

Submission Details

510(k) Number K200381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2020
Decision Date February 28, 2020
Days to Decision 10 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
112d faster than avg
Panel avg: 122d · This submission: 10d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.
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 - NKB Thoracolumbosacral Pedicle Screw System

All 661
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K200381.
Nano FortiFix® System
K193211 · Nanovis Spine, LLC · Mar 2020
MEGAFIX® Pedicle Screw Spinal System
K191655 · Seohancare Co., Ltd. · Mar 2020
LOSPA® IS™ Spinal Fixation System
K200267 · Corentec Co., Ltd. · Mar 2020
OrthoCircle Spine Pedicle Screw System
K193472 · Orthocircle Spine · Feb 2020
PERLA® TL posterior osteosynthesis system
K193396 · Spineart · Feb 2020
CapLOX II®/TowerLOX® MIS Pedicle Screw System
K193270 · Captiva Spine, Inc. · Jan 2020