Cleared Traditional

K180673 - Normandy VBR System

K180673 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 121-day FDA review.

K180673 · Zavation Medical Products, LLC · Orthopedic device
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Jul 2018
Decision
121d
Days
Class 2
Risk

K180673 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 July 13, 2018 after a review of 121 days - within the typical 510(k) review window.

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 Zavation Medical Products, LLC devices

Submission Details

510(k) Number K180673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2018
Decision Date July 13, 2018
Days to Decision 121 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
1d faster than avg
Panel avg: 122d · This submission: 121d
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 K180673.
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
NuVasive X-CORE Mini Cervical Expandable VBR System
K151651 · Nu Vasive, Incorporated · Sep 2015