Cleared Special

K223731 - NuVasive Modulus-C Interbody System

K223731 is the FDA 510(k) clearance for NuVasive Modulus-C Interbody System by Nuvasive, Inc.. It is a Class 2 Orthopedic device (product code ODP) cleared through the Special 510(k) pathway after a 30-day FDA review.

K223731 · Nuvasive, Inc. · Orthopedic device
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Jan 2023
Decision
30d
Days
Class 2
Risk

K223731 is an FDA 510(k) clearance for the NuVasive Modulus-C Interbody System. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Nuvasive, Inc. (San Diego, US). The FDA issued a Cleared decision on January 12, 2023 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Nuvasive, Inc. devices

Submission Details

510(k) Number K223731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2022
Decision Date January 12, 2023
Days to Decision 30 days
Submission Type Special
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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 218
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K223731.
Curiteva Porous PEEK Cervical Interbody Fusion System
K213030 · Curiteva, Inc. · Feb 2023
Eminent Spine 3D Cervical Interbody Fusion System
K212701 · Eminent Spine · Feb 2023
Manta Ray TDF Spacer
K220296 · SeaSpine Orthopedics Corporation · Feb 2023
Cervical Spine Truss System (CSTS) Interbody Fusion Device
K221266 · 4Web Medical, Inc. · Jan 2023
Kodiak C Spinal Implant System
K222806 · Met One Technologies, LLC · Dec 2022
Matrix HA Fusion Porous Cervical IBF System
K223510 · Innovasis, Inc. · Dec 2022