Cleared Special

K181590 - Neurostructures Cavetto® [MAX] Cervical Cage System

K181590 is an FDA 510(k) clearance for Neurostructures Cavetto [MAX] Cervical ..., manufactured by Neurostructures, Inc.. The device is a Class 2 Orthopedic device with product code ODP cleared through the Special 510(k) pathway after a 143-day FDA review.

K181590 · Neurostructures, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2018
Decision
143d
Days
Class 2
Risk

K181590 is an FDA 510(k) clearance for the Neurostructures Cavetto® [MAX] Cervical Cage System. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Neurostructures, Inc. (Irvine, US). The FDA issued a Cleared decision on November 8, 2018 after a review of 143 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. 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.

FDA 510(k) Submission Details - K181590

510(k) Number K181590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2018
Decision Date November 08, 2018
Days to Decision 143 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
21d slower than avg
Panel avg: 122d · This submission: 143d
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

Empirical Testing Corp
Meredith Lee May

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 352
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K181590.
Tyber Medical PT Interbody Spacer
K182284 · Tyber Medical, LLC · Jan 2019
REVEL Spacers
K180909 · Globus Medical, Inc. · Dec 2018
Axis Chena Cervical PEEK Spacer System
K181140 · Axis Orthopaedics · Nov 2018
TirboLOX-C Cervical IBFD
K181229 · Captiva Spine, Inc. · Sep 2018
ACCUFUSE Cervical System
K181471 · Absolute Advantage Medical, LLC · Aug 2018
ATEC Cervical Spacer System
K181435 · Alphatec Spine, Inc. · Aug 2018
K181590 · Neurostructures Cavetto® [MAX] Cervical Cage System
Download PDF FDA Summary Neurostructures, Inc.