PMA
P120024: ACTIVL ARTIFICIAL DISC
FDA PMA · Prosthesis, intervertebral disc · Highridge Medical, LLC
Key facts
| PMA number | P120024 |
|---|---|
| Trade name | ACTIVL ARTIFICIAL DISC |
| Generic name | Prosthesis, intervertebral disc |
| Applicant | Highridge Medical, LLC |
| Owner/operator | AESCULAP, INC. |
| Product code | MJO |
| Approval date | Jun 11, 2015 |
| Docket number | 15M-2218 |
| Notice date | Jul 17, 2015 |
| Establishment registration | 2916714 |
| FEI number | 2916714 |
At a glance
- 10–99 Supplements
- Jan 29, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: