PMA
P170036: M6-C Artificial Cervical Disc
FDA PMA · Prosthesis, intervertebral disc · Spinal Kinetics, LLC
Key facts
| PMA number | P170036 |
|---|---|
| Trade name | M6-C Artificial Cervical Disc |
| Generic name | Prosthesis, intervertebral disc |
| Applicant | Spinal Kinetics, LLC |
| Owner/operator | Orthofix US LLC |
| Product code | MJO |
| Approval date | Feb 6, 2019 |
| Docket number | 19M-0645 |
| Notice date | Feb 11, 2019 |
| Establishment registration | 2183449 |
| FEI number | 2183449 |
At a glance
- 10–99 Supplements
- Aug 19, 2024 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 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: