Cleared Special

K170074 - nvc (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K170074 · Nvision Biomedical Technologies, LLC · Orthopedic device
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.

Submission Details

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
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 116d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 Peers - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 38
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K170074.
Flex-Z™ Cervical Cage
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Hive™ Standalone Cervical System and Hive™ C Interbody System
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Curiteva Porous PEEK Cervical Interbody System
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Curiteva Porous PEEK Cervical Interbody Fusion System
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Cervical Interbody and VBR Fusion System
K252219 · Sync Surgical · Jan 2026
Advantage-C™ Ti3D Cervical Interbody Fusion Device
K252711 · Intelivation Technologies · Jan 2026