HDE
H010002: OP-1 IMPLANT
FDA Humanitarian Device Exemption · OLYMPUS BIOTECH CORPORATION
Key facts
| HDE number | H010002 |
|---|---|
| Trade name | OP-1 IMPLANT |
| Generic name | Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction - hde, long bone nonunion |
| Applicant | OLYMPUS BIOTECH CORPORATION |
| Product code | OKD |
| Approval date | Oct 17, 2001 |
| Docket number | 01M-0482 |
At a glance
- 10–99 Supplements
- Jul 26, 2013 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- 1–9 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: