Identity
- Trade Name
- CHARITE ARTIFICIAL DISC FDA PMA
- Generic Name
- Prosthesis, intervertebral disc FDA PMA
Identifiers
- PMA Number
- P040006 FDA PMA
- FDA Product Code
- MJO FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Orthopedic FDA PMA
- FDA Decision
- APWD FDA PMA
The Charite Artificial Disc is a prosthesis, intervertebral disc indicated for spinal arthroplasty in skeletally mature patients with degenerative disc disease (DDD) at one level from L4-S1. DDD is defined as discogenic back pain with disc degeneration confirmed by patient history and radiographic studies.
It is supplied by Depuy Spine, Inc. and has received FDA PMA approval (P040006). The device is intended for use in patients with no more than 3 mm of spondylolisthesis at the involved level who have failed at least six months of conservative treatment prior to implantation.
Frequently asked questions
What is the Charite Artificial Disc indicated for?
The Charite Artificial Disc is indicated for spinal arthroplasty in skeletally mature patients with degenerative disc disease (DDD) at one level from L4-S1, where DDD is defined as discogenic back pain with disc degeneration confirmed by patient history and radiographic studies.
What patient criteria must be met for implantation of the Charite Artificial Disc?
Patients must have no more than 3 mm of spondylolisthesis at the involved level and must have failed at least six months of conservative treatment prior to implantation of the Charite Artificial Disc.
What regulatory authorization does the Charite Artificial Disc have?
The Charite Artificial Disc has received FDA PMA approval, as indicated by the authorization field FDA_PMA and the PMA number P040006 in the device data.
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 | P040006 | Class III | Active |
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Manufacturer
- Manufacturer
- Depuy Spine, Inc.
Sources (1)
- FDA PMA P040006 24 fields · synced Sep 18, 2026