HDE supplement
H020008 S010: OP-1 PUTTY FOR POSTEROLATERAL SPINAL FUSIONS
FDA HDE supplement · normal 75 day track · OLYMPUS BIOTECH CORPORATION
Key facts
| Original HDE | H020008 |
|---|---|
| Supplement number | S010 |
| Supplement type | normal 75 day track |
| Reason for the supplement | process change - manufacturer/sterilizer/packager/supplier |
| 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 |
| Received date | Aug 14, 2006 |
| Decision date | May 25, 2007 |
At a glance
- No Approval order on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE supplements
An HDE supplement asks FDA to approve a change to a Humanitarian Use Device that already holds a humanitarian device exemption.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: