Cleared Traditional

K173882 - SeaSpine Mariner Pedicle Screw System

K173882 is the FDA 510(k) clearance for SeaSpine Mariner Pedicle Screw System by SeaSpine Orthopedics Corporation. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K173882 · SeaSpine Orthopedics Corporation · Orthopedic device
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Feb 2018
Decision
47d
Days
Class 2
Risk

K173882 is an FDA 510(k) clearance for the SeaSpine Mariner Pedicle Screw 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 6, 2018 after a review of 47 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all SeaSpine Orthopedics Corporation devices

Submission Details

510(k) Number K173882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2017
Decision Date February 06, 2018
Days to Decision 47 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
75d faster than avg
Panel avg: 122d · This submission: 47d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K173882.
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Wiltrom Spinal Fixation System
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VERTICALE® Posterior Spinal Fixation System/VERTICALE® System
K171421 · Silony Medical GmbH · Jan 2018