Cleared Traditional

K200953 - NuVasive Cohere Thoracolumbar Interbody...

K200953 is the FDA 510(k) clearance for NuVasive Cohere Thoracolumbar Interbody... by Nu Vasive, Incorporated. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K200953 · Nu Vasive, Incorporated · Orthopedic device
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Oct 2020
Decision
180d
Days
Class 2
Risk

K200953 is an FDA 510(k) clearance for the NuVasive® Cohere® Thoracolumbar Interbody 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 October 6, 2020 after a review of 180 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 Nu Vasive, Incorporated devices

Submission Details

510(k) Number K200953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2020
Decision Date October 06, 2020
Days to Decision 180 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
58d slower than avg
Panel avg: 122d · This submission: 180d
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 K200953.
Zavation IBF System
K202305 · Zavation Medical Products, LLC · Oct 2020
GAIA Lumbar Interbody Fusion Device (LIFD) Family
K201939 · Printerprezz · Oct 2020
Fortilink Cages with TiPlus Technology
K201453 · Paradigm Spine GmbH · Oct 2020
NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Standalone System and Brigade Hyperlordotic System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, 3DP Interfixated ALIF System
K201820 · Nu Vasive, Incorporated · Sep 2020
FlareHawk TiHawk9 Interbody Fusion System
K201367 · Integrity Implants, Inc. · Sep 2020
X-Pac Expandable Lumbar Cage System
K201145 · Expanding Innovations, Inc. · Sep 2020