HDE
H040004: INFUSE/MASTERGRAFT CERAMIC OR INFUSE HDE KIT
FDA Humanitarian Device Exemption · MEDTRONIC SOFAMOR DANEK, INC.
Key facts
| HDE number | H040004 |
|---|---|
| Trade name | INFUSE/MASTERGRAFT CERAMIC OR INFUSE HDE KIT |
| Generic name | Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction - hde |
| Applicant | MEDTRONIC SOFAMOR DANEK, INC. |
| Owner/operator | Medtronic, Inc. |
| Product code | OJZ |
| Approval date | Oct 10, 2008 |
| Docket number | 08M0562 |
| Establishment registration | 1030489 |
| FEI number | 1000477302 |
At a glance
- None Supplements
- Oct 10, 2008 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- None 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 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: