Cleared Traditional

K201646 - Shoreline ACS (Anterior Cervical System)

K201646 is the FDA 510(k) clearance for Shoreline ACS (Anterior Cervical System) by SeaSpine Orthopedics Corporation. It is a Class 2 Orthopedic device (product code OVE) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K201646 · SeaSpine Orthopedics Corporation · Orthopedic device
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Sep 2020
Decision
89d
Days
Class 2
Risk

K201646 is an FDA 510(k) clearance for the Shoreline ACS (Anterior Cervical System). Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by SeaSpine Orthopedics Corporation (Carlsbad, US). The FDA issued a Cleared decision on September 14, 2020 after a review of 89 days - a notably fast clearance cycle.

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: 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 K201646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2020
Decision Date September 14, 2020
Days to Decision 89 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
33d faster than avg
Panel avg: 122d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OVE Intervertebral Fusion Device With Integrated Fixation, 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 With Or Without Supplemental Fixation.
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 - OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

All 114
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K201646.
Hexanium® ACIF
K193000 · Spinevision, S.A.S. · Oct 2020
Cavetto-SA Cervical Cage System
K200115 · Neurostructures, Inc. · Sep 2020
Seaspine WaveForm C Interbody System
K201073 · SeaSpine Orthopedics Corporation · Sep 2020
F3D Cervical Stand-Alone Interbody Fusion System
K200087 · Corelink, LLC · Jun 2020
SPIRA-C Integrated Fixation System
K193153 · Camber Spine Technologies · Apr 2020
NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System
K200543 · Nexxt Spine, LLC · Mar 2020