Prosthesis, Intervertebral Disc
The Intervertebral Disc Prosthesis is a surgically implanted device designed to replace a diseased or degenerated intervertebral disc in the spine, restoring disc height and allowing segmental motion to reduce pain and improve spinal function in patients with degenerative disc disease. As a Class 3 implantable device, it requires Premarket Approval (PMA) due to the critical nature of spinal implantation and the significant risks associated with disc arthroplasty. It carries an implant flag, and no regulation number or medical specialty code is recorded in the classification database.
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Basic Information
- Product Code
- MJO
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- OR
- Submission Type
- 2
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 74 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 74 registration numbers. Click on an entry to view related FDA registrations.