Product code
PJM: Filler, bone void, alterable compound for cranioplasty
FDA product code · Class II · Neurology
Key facts
| Product code | PJM |
|---|---|
| Device | Filler, bone void, alterable compound for cranioplasty |
| Device class | Class II |
| Regulation number | 882.5320 |
| Review panel | Neurology |
| Medical specialty | Neurology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | Yes |
| Life-sustaining or life-supporting | No |
| Definition | An alterable cranial bone void filler is a device intended to be a bone substitute for the replacement of bony voids, defects, and contour irregularities in non-load bearing regions of the cranial skeleton, and are not intrinsic to the stability of the bony structure. The device is constructed from a material (e.g., calcium, polymer synthetic-based, etc.) that can be reshaped or altered at the… |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- None UDI devices (GUDID)
- 1–9 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