Cleared Traditional

K231836 - ClariVy Cervical IBF System

K231836 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 Traditional 510(k) pathway after a 130-day FDA review.

K231836 · Vy Spine, LLC · Orthopedic device
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Oct 2023
Decision
130d
Days
Class 2
Risk

K231836 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 October 30, 2023 after a review of 130 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 Vy Spine, LLC devices

Submission Details

510(k) Number K231836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2023
Decision Date October 30, 2023
Days to Decision 130 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
8d slower than avg
Panel avg: 122d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K231836.
Peridot-PT Anterior Cervical Intervertebral body fusion System
K233839 · Gbs Commonwealth Co., Ltd. · Dec 2023
Align Cervical Interbody Fusion System
K230639 · Acuity Surgical Devices, LLC · Dec 2023
Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system
K233084 · Gbs Commonwealth Co., Ltd. · Nov 2023
Acro Composites Interbody System
K230478 · Acro Composites, LLC · Oct 2023
HAtetracell™-C Titanium Cervical IBF System
K231899 · Innovasis, Inc. · Oct 2023
Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior cervical interbody fusion - ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system)
K232822 · Gbs Commonwealth Co., Ltd. · Oct 2023