Identity
- Trade Name
- M6-C Artificial Cervical Disc FDA PMA
- Generic Name
- Prosthesis, intervertebral disc FDA PMA
Identifiers
- PMA Number
- P170036 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 M6-C Artificial Cervical Disc is a prosthesis, intervertebral disc indicated for reconstruction of the disc following single level discectomy in skeletally mature patients with intractable degenerative cervical radiculopathy with or without spinal cord compression at one level from C3 to C7. It is implanted via an anterior approach after failure of at least 6 weeks of conservative treatment or presence of progressive neurological symptoms.
Supplied as a sterile, single-use implant for surgical use in hospital settings. The device is authorized under FDA PMA (P170036) and is classified as a Class III medical device. No information on MRI safety, sizes, or storage conditions is provided in the source data.
Frequently asked questions
What is the M6-C Artificial Cervical Disc used for?
The M6-C Artificial Cervical Disc is used for reconstruction of the disc following a single-level discectomy in skeletally mature patients who have intractable degenerative cervical radiculopathy with or without spinal cord compression at one level from C3 to C7, as confirmed by radiographic imaging such as CT, MRI, or x-rays.
Who manufactures the M6-C Artificial Cervical Disc and what regulatory pathway was used?
The M6-C Artificial Cervical Disc is manufactured by Spinal Kinetics, LLC and received FDA Premarket Approval (PMA) under application number P170036, with the decision date of February 6, 2019.
Is the M6-C Artificial Cervical Disc reusable or single-use?
The M6-C Artificial Cervical Disc is supplied as a sterile, single-use implant intended for one-time surgical implantation via an anterior approach, based on the indications and usage described in the authorization documentation.
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 | P170036 | Class III | Active |
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Manufacturer
- Manufacturer
- Spinal Kinetics, LLC
Sources (1)
- FDA PMA P170036 24 fields · synced Sep 18, 2026