HDE
H020008: OP-1 PUTTY FOR POSTEROLATERAL SPINAL FUSIONS
FDA Humanitarian Device Exemption · OLYMPUS BIOTECH CORPORATION
Key facts
| HDE number | H020008 |
|---|---|
| Trade name | OP-1 PUTTY FOR POSTEROLATERAL SPINAL FUSIONS |
| Generic name | Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction - hde |
| Applicant | OLYMPUS BIOTECH CORPORATION |
| Product code | OJZ |
| Approval date | Apr 7, 2004 |
| Docket number | 04M-0165 |
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)
- 1–9 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: