Product code
OKD: Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction - hde, long bone nonunion
FDA product code · HDE · Orthopedic
Key facts
| Product code | OKD |
|---|---|
| Device | Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction - hde, long bone nonunion |
| Device class | HDE |
| Review panel | Orthopedic |
| Submission type | HDE - Humanitarian Device Exemption |
| GMP exempt | No |
| Implanted device | Yes |
| Life-sustaining or life-supporting | No |
| Definition | Bone graft substitute when autograft is unavailable or unfeasible to harvest for treatment of recalcitrant long bone non-unions where normal bone metabolism and healing is not present, e.g., smokers and diabetics. |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- 1–9 HDE approvals
- None UDI devices (GUDID)
- None MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database