Cleared Special

K170074 - nvc

K170074 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 Special 510(k) pathway after a 15-day FDA review.

K170074 · Nvision Biomedical Technologies, LLC · Orthopedic device
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Jan 2017
Decision
15d
Days
Class 2
Risk

K170074 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 January 24, 2017 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Nvision Biomedical Technologies, LLC devices

FDA 510(k) Submission Details - K170074

510(k) Number K170074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2017
Decision Date January 24, 2017
Days to Decision 15 days
Submission Type Special
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
107d faster than avg
Panel avg: 122d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

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

Acknowledge Regulatory Strategies, LLC
Allison Komiyama

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 K170074.
NuVasive CoRoent Small Interbody System
K163491 · Nu Vasive, Incorporated · Mar 2017
4CIS® Marlin ACIF Cage System
K162402 · Solco Biomedical Co., Ltd. · Feb 2017
ROCCIA® ACIF
K162587 · Silony Medical GmbH · Jan 2017
Ayers Rock Cervical interbody fusion system
K162694 · Spineway · Jan 2017
The Small PLATEAU (PLATEAU-C) Spacer System
K161127 · Life Spine, Inc. · Dec 2016
IMSE Cervical Cage
K162003 · The Institute of Musculoskeletal Science & Education · Dec 2016