PMA
P160036: Hintermann Series H3 Total Ankle Replacement System
FDA PMA · Prosthesis, ankle, uncemented, non-constrained · Dt Medtech, LLC
Key facts
| PMA number | P160036 |
|---|---|
| Trade name | Hintermann Series H3 Total Ankle Replacement System |
| Generic name | Prosthesis, ankle, uncemented, non-constrained |
| Applicant | Dt Medtech, LLC |
| Owner/operator | DT MedTech LLC |
| Product code | NTG |
| Approval date | Jun 4, 2019 |
| Docket number | 19M-2732 |
| Notice date | Jun 25, 2019 |
| Establishment registration | 3012104767 |
| FEI number | 3012104767 |
At a glance
- 1–9 Supplements
- Jul 31, 2026 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- No Withdrawn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: