Cleared Traditional

K162496 - Foundation 3D Interbody

K162496 is an FDA 510(k) clearance for Foundation 3D Interbody, manufactured by Corelink, LLC. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K162496 · Corelink, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
239d
Days
Class 2
Risk

K162496 is an FDA 510(k) clearance for the Foundation 3D Interbody. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Corelink, LLC (St. Louis, US). The FDA issued a Cleared decision on May 4, 2017 after a review of 239 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

FDA 510(k) Submission Details - K162496

510(k) Number K162496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2016
Decision Date May 04, 2017
Days to Decision 239 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
117d slower than avg
Panel avg: 122d · This submission: 239d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ODP Device Classification - Class 2, Special Controls

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 Consultant

Empirical Testing Corp
Kenneth C. Maxwell II

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 - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 336
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K162496.
Summit Spine Channel Cervical Interbody Fusion System
K163494 · Summit Spine · Jun 2017
MATISSE Anterior Cervical Interbody Fusion Cage System
K162682 · Ctl Medical Corporation · Jun 2017
Fortilink™-C with TETRAfuse™ 3D Technology
K163673 · Rti Surgical, Inc. · May 2017
Kepler II
K163265 · Orbbo Surgical, LLC · Apr 2017
NuVasive CoRoent Small Interbody System
K163491 · Nu Vasive, Incorporated · Mar 2017
4CIS® Marlin ACIF Cage System
K162402 · Solco Biomedical Co., Ltd. · Feb 2017