Cleared Traditional

K191423 - Normandy VBR System

K191423 is the FDA 510(k) clearance for Normandy VBR System by Zavation Medical Products, LLC. It is a Class 2 Orthopedic device (product code PLR) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K191423 · Zavation Medical Products, LLC · Orthopedic device
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Aug 2019
Decision
69d
Days
Class 2
Risk

K191423 is an FDA 510(k) clearance for the Normandy VBR System. Classified as Spinal Vertebral Body Replacement Device - Cervical (product code PLR), Class II - Special Controls.

Submitted by Zavation Medical Products, LLC (Flowood, US). The FDA issued a Cleared decision on August 6, 2019 after a review of 69 days - a notably fast clearance 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: 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 Zavation Medical Products, LLC devices

Submission Details

510(k) Number K191423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2019
Decision Date August 06, 2019
Days to Decision 69 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
53d faster than avg
Panel avg: 122d · This submission: 69d
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 K191423.
Bengal Stackable Cage System
K190284 · Medos International SARL · Dec 2019
ALTA Anterior Cervical Corpectomy System
K190426 · Astura Medical, LLC · Oct 2019
Omnia Medical VBR
K191778 · Omnia Medical, LLC · Aug 2019
VLIFT-s Vertebral Body Replacement System
K183071 · Stryker Spine · Jan 2019
NuVasive Monolith Cervical Corpectomy System
K180550 · Nu Vasive, Incorporated · Nov 2018
Trabis
K173893 · Coligne AG · Sep 2018