HDE
H980002: PROXIMAL INTERPHALANGEAL (PIP) FINGER JOINT
FDA Humanitarian Device Exemption · Encore Medical L/P. d/b/a DJO Surgical
Key facts
| HDE number | H980002 |
|---|---|
| Trade name | PROXIMAL INTERPHALANGEAL (PIP) FINGER JOINT |
| 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 | Sep 28, 1998 |
| Docket number | 98M-0895 |
| Establishment registration | 1644408 |
| FEI number | 1000116912 |
At a glance
- 10–99 Supplements
- Jun 26, 2024 Latest supplement decision
- No Summary of safety and probable benefit on file
- 10–99 UDI device identifiers (GUDID)
- 10–99 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: