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Mobi-C Cervical Disc Prosthesis (One-Level Indication)

FDA PMA

Class III (US FDA PMA)

PMA P110002

by Highridge Medical, LLC

Identity

Trade Name
MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION) FDA PMA
Generic Name
Prosthesis, intervertebral disc FDA PMA

Identifiers

PMA Number
P110002 FDA PMA
FDA Product Code
MJO FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Orthopedic FDA PMA
FDA Decision
APPR Approved FDA PMA

The Mobi-C Cervical Disc Prosthesis is a prosthetic intervertebral disc designed for spinal reconstruction. It is intended for use in skeletally mature patients to replace a single cervical disc level (C3–C7) following discectomy for intractable radiculopathy, with or without neck pain or myelopathy, when conservative treatment has failed or symptoms persist despite nonoperative care.

Implanted via an anterior approach, the device is supplied sterile and intended for single-use. It is classified as a Class III medical device under FDA regulations and requires a Premarket Approval (PMA). Available in multiple sizes, the prosthesis is regulated under product code MJO and is authorized for use in cervical spine reconstruction as specified in the PMA approval (P110002).

Frequently asked questions

What is the Mobi-C Cervical Disc Prosthesis used for?

The Mobi-C Cervical Disc Prosthesis is designed for spinal reconstruction in skeletally mature patients to replace a single cervical disc level (C3-C7) following discectomy for intractable radiculopathy, with or without neck pain or myelopathy, when conservative treatment has failed.

How is the Mobi-C Cervical Disc Prosthesis supplied?

The device is supplied sterile and is intended for single-use only. It is implanted via an anterior approach during surgical procedures.

What sizes are available for the Mobi-C Cervical Disc Prosthesis?

The Mobi-C Cervical Disc Prosthesis is available in multiple sizes to accommodate different patient anatomies, though specific size dimensions are not detailed in the provided information.

What is the regulatory classification of the Mobi-C Cervical Disc Prosthesis?

The device is classified as a Class III medical device under FDA regulations and requires Premarket Approval (PMA). It is regulated under product code MJO and has PMA number P110002.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Highridge Medical, LLC

Sources (1)

  • FDA PMA P110002 24 fields · synced Sep 18, 2026