Cleared Traditional

K142328 - nvc

K142328 is an FDA 510(k) clearance for nvc, manufactured by Nvision Biomedical Technologies, LLC. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K142328 · Nvision Biomedical Technologies, LLC · Orthopedic device
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Dec 2014
Decision
125d
Days
Class 2
Risk

K142328 is an FDA 510(k) clearance for the nvc. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Nvision Biomedical Technologies, LLC (San Antonio, US). The FDA issued a Cleared decision on December 23, 2014 after a review of 125 days - within the typical 510(k) review window.

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 Nvision Biomedical Technologies, LLC devices

FDA 510(k) Submission Details - K142328

510(k) Number K142328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2014
Decision Date December 23, 2014
Days to Decision 125 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
3d slower than avg
Panel avg: 122d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ODP Device Classification - Class 2, Special Controls

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 Consultant

Jalex Medical, LLC
JENNIFER PALINCHIK

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 336
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K142328.
Coalition AGX Plate and Coalition AGX Spacer
K142218 · Globus Medical, Inc. · Mar 2015
Talos-C(HA) Cervical Intervertebral Body Fusion Devices
K142345 · Meditech Spine, LLC · Feb 2015
CONSTRUX MINI PEEK
K142152 · Orthofix, Inc. · Jan 2015
POROSTEON PHUSION METAL CERVICAL CAGE
K142041 · Porosteon, Inc. · Dec 2014
Valeo C Spacer System, Valeo II C IBF Device
K142264 · Amedica Corp. · Dec 2014
ARENA-C TIFUSE CERVICAL INTERVERTEBRAL BODY FUSION DEVICE
K141333 · Spinefrontier, Inc. · Nov 2014