Cleared Special

K181590 - Neurostructures Cavetto [MAX] Cervical ...

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

K181590 · Neurostructures, Inc. · Orthopedic device
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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.

View all Neurostructures, Inc. devices

Submission Details

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.

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 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 208
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