- Device
- Aesculap activL Artificial Disc
- Applicant
- Highridge Medical, LLC
- PMA number
- P120024
- Supplement
- S011
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2020-01-31
- Decision code
- APPR
- Date received
- 2019-12-06
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order 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.