Cleared Traditional

K200087 - F3D Cervical Stand-Alone Interbody Fusi...

K200087 is the FDA 510(k) clearance for F3D Cervical Stand-Alone Interbody Fusi... by Corelink, LLC. It is a Class 2 Orthopedic device (product code OVE) cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K200087 · Corelink, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2020
Decision
152d
Days
Class 2
Risk

K200087 is an FDA 510(k) clearance for the F3D Cervical Stand-Alone Interbody Fusion System. Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by Corelink, LLC (St. Louis, US). The FDA issued a Cleared decision on June 15, 2020 after a review of 152 days - an extended review 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: 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 Corelink, LLC devices

Submission Details

510(k) Number K200087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 2020
Decision Date June 15, 2020
Days to Decision 152 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
30d slower than avg
Panel avg: 122d · This submission: 152d
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 Consultant

Empirical Testing Corp
Nathan Wright

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

All 110
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K200087.
Cavetto-SA Cervical Cage System
K200115 · Neurostructures, Inc. · Sep 2020
Seaspine WaveForm C Interbody System
K201073 · SeaSpine Orthopedics Corporation · Sep 2020
Shoreline ACS (Anterior Cervical System)
K201646 · SeaSpine Orthopedics Corporation · Sep 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
Mecta-C Stand Alone
K192906 · Medacta International S.A. · Mar 2020