Cleared Traditional

K180550 - NuVasive Monolith Cervical Corpectomy S...

K180550 is the FDA 510(k) clearance for NuVasive Monolith Cervical Corpectomy S... by Nu Vasive, Incorporated. It is a Class 2 Orthopedic device (product code PLR) cleared through the Traditional 510(k) pathway after a 264-day FDA review.

K180550 · Nu Vasive, Incorporated · Orthopedic device
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Nov 2018
Decision
264d
Days
Class 2
Risk

K180550 is an FDA 510(k) clearance for the NuVasive Monolith Cervical Corpectomy System. Classified as Spinal Vertebral Body Replacement Device - Cervical (product code PLR), Class II - Special Controls.

Submitted by Nu Vasive, Incorporated (San Diego, US). The FDA issued a Cleared decision on November 20, 2018 after a review of 264 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 K180550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2018
Decision Date November 20, 2018
Days to Decision 264 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
142d slower than avg
Panel avg: 122d · This submission: 264d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PLR Spinal Vertebral Body Replacement Device - Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
Definition Vertebral Body Replacement In The Cervical Spine.
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 - PLR Spinal Vertebral Body Replacement Device - Cervical

All 15
Devices cleared under the same product code (PLR) and FDA review panel - the closest regulatory comparables to K180550.
Omnia Medical VBR
K191778 · Omnia Medical, LLC · Aug 2019
Normandy VBR System
K191423 · Zavation Medical Products, LLC · Aug 2019
VLIFT-s Vertebral Body Replacement System
K183071 · Stryker Spine · Jan 2019
Trabis
K173893 · Coligne AG · Sep 2018
Normandy VBR System
K180673 · Zavation Medical Products, LLC · Jul 2018
NuVasive X-CORE Mini Cervical Expandable VBR System
K151651 · Nu Vasive, Incorporated · Sep 2015