Cleared Traditional

K190655 - SeaSpine Shoreline ACS- Anterior Cervic...

K190655 is the FDA 510(k) clearance for SeaSpine Shoreline ACS- Anterior Cervic... by SeaSpine Orthopedics Corporation. It is a Class 2 Orthopedic device (product code OVE) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K190655 · SeaSpine Orthopedics Corporation · Orthopedic device
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Apr 2019
Decision
46d
Days
Class 2
Risk

K190655 is an FDA 510(k) clearance for the SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone 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 April 29, 2019 after a review of 46 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 K190655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2019
Decision Date April 29, 2019
Days to Decision 46 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
76d faster than avg
Panel avg: 122d · This submission: 46d
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 K190655.
Elevation Spine Saber-C System
K190885 · Elevation Spine · Aug 2019
Endoskeleton TCS Interbody Fusion Device
K191565 · Titan Spine, Inc. · Aug 2019
NEXXT MATRIXX Stand Alone Cervical System
K190546 · Nexxt Spine, LLC · May 2019
Stable-C Interbody System
K181621 · Nexus Spine, LLC · Oct 2018
MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate
K182151 · Ctl Medical Corporation · Oct 2018
Genesys Spine AIS-C Cervical Stand-Alone System
K181295 · Genesys Spine · Aug 2018