Cleared Traditional

K170962 - NuVasive CoRoent Thoracolumbar System

K170962 is the FDA 510(k) clearance for NuVasive CoRoent Thoracolumbar System by Nu Vasive, Incorporated. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K170962 · Nu Vasive, Incorporated · Orthopedic device
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Jun 2017
Decision
87d
Days
Class 2
Risk

K170962 is an FDA 510(k) clearance for the NuVasive® CoRoent® Thoracolumbar System. Classified as Intervertebral Fusion Device With Bone Graft, Lumbar within the MAX classification (a category for intervertebral fusion devices and spinal implants), Class II - Special Controls.

Submitted by Nu Vasive, Incorporated (San Diego, US). The FDA issued a Cleared decision on June 26, 2017 after a review of 87 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 K170962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2017
Decision Date June 26, 2017
Days to Decision 87 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
35d faster than avg
Panel avg: 122d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize 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 - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 603
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K170962.
Rampart L Lumbar Interbody Fusion Device
K171724 · Spineology, Inc. · Jul 2017
CONCORDE LIFT
K171425 · Medos International SARL · Jul 2017
CRESCENT™ Spinal System
K171031 · Medtronic Sofamor Danek · Jul 2017
FUSE Spinal System
K171468 · Medtronic Sofamor Danek · Jun 2017
DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM
K162212 · Medtronic Sofamor Danek USA, Inc. · May 2017
MOJAVE Expandable Interbody System
K171097 · K2m, Inc. · May 2017