Cleared Traditional

K162138 - NuVasive CoRoent Small Ti-C System

K162138 is the FDA 510(k) clearance for NuVasive CoRoent Small Ti-C System by Nu Vasive, Incorporated. It is a Class 2 Orthopedic device (product code ODP) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K162138 · Nu Vasive, Incorporated · Orthopedic device
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Oct 2016
Decision
86d
Days
Class 2
Risk

K162138 is an FDA 510(k) clearance for the NuVasive CoRoent Small Ti-C System. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Nu Vasive, Incorporated (San Diego, US). The FDA issued a Cleared decision on October 26, 2016 after a review of 86 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 Nu Vasive, Incorporated devices

Submission Details

510(k) Number K162138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2016
Decision Date October 26, 2016
Days to Decision 86 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
36d faster than avg
Panel avg: 122d · This submission: 86d
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 223
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K162138.
Foundation 3D Interbody
K162496 · Corelink, LLC · May 2017
NuVasive CoRoent Small Interbody System
K163491 · Nu Vasive, Incorporated · Mar 2017
The Small PLATEAU (PLATEAU-C) Spacer System
K161127 · Life Spine, Inc. · Dec 2016
Ascential IBD PEEKc Spacer
K161407 · Stryker Spine · Jul 2016
ANATOMIC PEEK PTC Cervical Fusion System
K160528 · Medtronic Sofamor Danek USA, Inc. · Mar 2016
PERIMETER C (Titanium) Spinal System
K153438 · Medtronic Sofamor Danek USA, Inc. · Mar 2016