Cleared Special

Cavetto-SA Cervical Cage System (K200115) - FDA 510(k) Clearance

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

K200115 · Neurostructures, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2020
Decision
247d
Days
Class 2
Risk

K200115 is an FDA 510(k) clearance for the Cavetto-SA Cervical Cage System. Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by Neurostructures, Inc. (Irvine, US). The FDA issued a Cleared decision on September 24, 2020 after a review of 247 days - an extended review 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Neurostructures, Inc. devices

Submission Details

510(k) Number K200115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2020
Decision Date September 24, 2020
Days to Decision 247 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
125d slower than avg
Panel avg: 122d · This submission: 247d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OVE Intervertebral Fusion Device With Integrated Fixation, 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 With Or Without Supplemental Fixation.
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

Empirical Testing Corp
Nathan Wright

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 - OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

All 159
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K200115.
SABER-C System
K260660 · Elevation Spine · Apr 2026
SAGI Cervical Cage System
K253213 · ZheJiang Decans Medical Devices Co., Ltd. · Apr 2026
Uni-C Cervical Cage System
K252774 · ZheJiang Decans Medical Devices Co., Ltd. · Apr 2026
E3D™-C Interbody System
K260038 · Evolution Spine · Feb 2026
HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)
K253876 · Globus Medical, Inc. · Dec 2025
Cervical Spine Truss System - Stand Alone (CSTS-SA)
K253200 · 4Web Medical, Inc. · Dec 2025