LDR Spine Mobi-C Cervical Disc Prosthesis (Two Level)
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION) FDA PMA
- Generic Name
- Prosthesis, intervertebral disc FDA PMA
Identifiers
- PMA Number
- P110009 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 LDR Spine Mobi-C Cervical Disc Prosthesis is an intervertebral disc prosthesis designed for reconstruction of the disc from C3-C7 following discectomy at two contiguous levels. It is indicated for skeletally mature patients with intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain, or myelopathy due to abnormality localized to the disc space, confirmed by radiographic imaging.
The device is implanted using an anterior approach and should be used only after patients have failed at least 6 weeks of conservative treatment or demonstrated progressive signs or symptoms despite nonoperative treatment. The Mobi-C Cervical Disc Prosthesis is authorized under FDA PMA and is manufactured by Highridge Medical, LLC.
Frequently asked questions
What is the LDR Spine Mobi-C Cervical Disc Prosthesis used for?
The device is used for reconstruction of the disc from C3-C7 following discectomy at two contiguous levels in skeletally mature patients with intractable radiculopathy with or without neck pain, or myelopathy due to abnormality localized to the disc space.
What approach is used to implant the Mobi-C Cervical Disc Prosthesis?
The device is implanted using an anterior approach after patients have failed at least 6 weeks of conservative treatment or demonstrated progressive signs or symptoms despite nonoperative treatment.
What conditions must be confirmed by radiographic imaging for the device to be indicated?
The device is indicated when conditions such as herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height compared to adjacent levels are confirmed by radiographic imaging.
What is the generic name of the Mobi-C Cervical Disc Prosthesis?
The generic name of the device is Prosthesis, intervertebral disc, which is designed to replace a damaged cervical disc in the spine.
What is the trade name of the device with two-level indication?
The trade name of the device with two-level indication is MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION), manufactured by Highridge Medical, LLC.
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
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P110009 | Class III | Active |
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Manufacturer
- Manufacturer
- Highridge Medical, LLC
Sources (1)
- FDA PMA P110009 24 fields · synced Sep 18, 2026