HDE
H010001: METACARPAL PHALANGEAL JOINT IMPLANT
FDA Humanitarian Device Exemption · Encore Medical L/P. d/b/a DJO Surgical
Key facts
| HDE number | H010001 |
|---|---|
| Trade name | METACARPAL PHALANGEAL JOINT IMPLANT |
| Generic name | Semi-constrained metal/polymer finger joint prosthesis |
| Applicant | Encore Medical L/P. d/b/a DJO Surgical |
| Owner/operator | ENCORE MEDICAL, L.P. |
| Product code | MPK |
| Approval date | Aug 28, 2001 |
| Docket number | 01M-0392 |
| Establishment registration | 1644408 |
| FEI number | 1000116912 |
At a glance
- 1–9 Supplements
- Jun 26, 2024 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- 10–99 UDI device identifiers (GUDID)
- 1–9 MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE approvals
A Humanitarian Device Exemption (HDE) authorizes devices intended to benefit patients with rare diseases or conditions affecting small populations in the United States.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: