Cleared Special

K230414 - ClariVy Cervical IBF System

K230414 is the FDA 510(k) clearance for ClariVy Cervical IBF System by Vy Spine, LLC. It is a Class 2 Orthopedic device (product code ODP) cleared through the Special 510(k) pathway after a 85-day FDA review.

K230414 · Vy Spine, LLC · Orthopedic device
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May 2023
Decision
85d
Days
Class 2
Risk

K230414 is an FDA 510(k) clearance for the ClariVy™ Cervical IBF System. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Vy Spine, LLC (Tallahassee, US). The FDA issued a Cleared decision on May 12, 2023 after a review of 85 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 Vy Spine, LLC devices

Submission Details

510(k) Number K230414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2023
Decision Date May 12, 2023
Days to Decision 85 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
37d faster than avg
Panel avg: 122d · This submission: 85d
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 219
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K230414.
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