Cleared Traditional

K163491 - NuVasive CoRoent Small Interbody System

K163491 is an FDA 510(k) clearance for NuVasive CoRoent Small Interbody System, manufactured by Nu Vasive, Incorporated. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K163491 · Nu Vasive, Incorporated · Orthopedic device
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Mar 2017
Decision
102d
Days
Class 2
Risk

K163491 is an FDA 510(k) clearance for the NuVasive CoRoent Small Interbody 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 March 24, 2017 after a review of 102 days - within the typical 510(k) review window.

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 Nu Vasive, Incorporated devices

FDA 510(k) Submission Details - K163491

510(k) Number K163491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2016
Decision Date March 24, 2017
Days to Decision 102 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
20d faster than avg
Panel avg: 122d · This submission: 102d
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 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 K163491.
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K162402 · Solco Biomedical Co., Ltd. · Feb 2017
ROCCIA® ACIF
K162587 · Silony Medical GmbH · Jan 2017
nvc
K170074 · Nvision Biomedical Technologies, LLC · Jan 2017