Prosthesis, Intervertebral Disc
Basic Information
- Device Name
- Prosthesis, Intervertebral Disc
- Trade Name
- Aesculap activL Artificial Disc
- PMA Number
- P120024
- Supplement Number
- S011
- Device Class
- FDA Class 3
- Product Code
- MJO
- Generic Name
- Prosthesis, intervertebral disc
- Medical Specialty
- Unknown
- Advisory Committee
- Orthopedic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- January 31, 2020
- Date Received
- December 6, 2019
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Postapproval Study Protocol
- Expedited Review
- N
Advisory Committee Statement
Approval forfollowing changes to the activL® Artificial Disc Enhanced Safety Surveillance Survey:1) Section: Pain Management; Question 4: Add N/A checkbox to the column, Using Spike Endplate as now it is possible that a Surgeon implanters experience would exclude the Spike Endplate and only include the Keel Endplate;2) Section: Spike vs. Keel Endplate Design; HeaderRemove For Surgeons Outside the US ONLY as now it is possible that a Surgeon implanter within the U.S. will have the option of the Spike Endplate and Keel Endplate.The following change to the Aesculap activL® Artificial Disc Enhanced Safety Surveillance Study as follows:3) Appendix ARemove previous version of the activL® Artificial Disc Enhanced Safety Surveillance Survey and replaced it with the updated version reflecting the updates detailed above.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MJO | Prosthesis, Intervertebral Disc | FDA class 3 | Unknown |