Identity
- Trade Name
- PRODISC -L TOTAL DISC REPLACEMENT DEVICE FDA PMA
- Generic Name
- Prosthesis, intervertebral disc FDA PMA
Identifiers
- PMA Number
- P050010 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 ProDisc-L Total Disc Replacement is an intervertebral disc prosthesis indicated for spinal arthroplasty in skeletally mature patients with degenerative disc disease (DDD) at one level from L3-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies.
The device is intended for patients with no more than grade 1 spondylolisthesis at the involved level who have failed at least six months of conservative treatment prior to implantation. The ProDisc-L Total Disc Replacement is a single-use device that requires FDA PMA authorization for use in spinal arthroplasty procedures.
Frequently asked questions
What is the ProDisc-L Total Disc Replacement used for?
The ProDisc-L Total Disc Replacement is used for spinal arthroplasty in skeletally mature patients with degenerative disc disease (DDD) at one level from L3-S1, defined as discogenic back pain with degeneration confirmed by patient history and radiographic studies.
What are the patient eligibility criteria for the ProDisc-L device?
Patients must be skeletally mature with DDD at one level from L3-S1, have no more than grade 1 spondylolisthesis at the involved level, and have failed at least six months of conservative treatment prior to implantation.
Is the ProDisc-L device single-use or reusable?
The ProDisc-L Total Disc Replacement is a single-use device that requires FDA PMA authorization for use in spinal arthroplasty procedures.
What regulatory authorization does the ProDisc-L device have?
The ProDisc-L Total Disc Replacement has FDA PMA authorization for use in spinal arthroplasty procedures.
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 | P050010 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Centinel Spine, LLC
Sources (1)
- FDA PMA P050010 24 fields · synced Sep 18, 2026