Cleared Traditional

K183083 - Shoreline Cervical Interbody RT System

K183083 is the FDA 510(k) clearance for Shoreline Cervical Interbody RT System by SeaSpine Orthopedics Corporation. It is a Class 2 Orthopedic device (product code ODP) cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K183083 · SeaSpine Orthopedics Corporation · Orthopedic device
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Feb 2019
Decision
100d
Days
Class 2
Risk

K183083 is an FDA 510(k) clearance for the Shoreline Cervical Interbody RT System. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by SeaSpine Orthopedics Corporation (Carlsbad, US). The FDA issued a Cleared decision on February 14, 2019 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - 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 SeaSpine Orthopedics Corporation devices

Submission Details

510(k) Number K183083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2018
Decision Date February 14, 2019
Days to Decision 100 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
22d faster than avg
Panel avg: 122d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ODP Intervertebral Fusion Device With Bone Graft, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.
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 - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 219
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K183083.
nvc
K190380 · Nvision Biomedical Technologies, Inc. · Mar 2019
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K183397 · Choicespine, LP · Mar 2019
SCARLET® AC-T Secured Anterior Cervical Cage
K190322 · Spineart · Mar 2019
Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Device, Endoskeleton® TL Interbody Fusion Device, Endoskeleton® TA Vertebral Body Replacement (VBR) Device
K183557 · Titan Spine, Inc. · Feb 2019
Velofix Interbody Fusion System
K190067 · U&I Corporation · Feb 2019
Cervical Spacer
K182477 · Additive Implants, LLC · Jan 2019