PMA
P860005: PRO OSTEON IMPLANT 500 HYDROXYAPATITE BONE VOID FILLER
FDA PMA · Calcium salt bone void filler, drillable, non-screw augmentation · Interpore Intl.
Key facts
| PMA number | P860005 |
|---|---|
| Trade name | PRO OSTEON IMPLANT 500 HYDROXYAPATITE BONE VOID FILLER |
| Generic name | Calcium salt bone void filler, drillable, non-screw augmentation |
| Applicant | Interpore Intl. |
| Owner/operator | Diality Inc |
| Product code | OIS |
| Approval date | Oct 29, 1992 |
| Docket number | 92M-0450 |
| Notice date | Apr 19, 1993 |
| Establishment registration | 3015349756 |
| FEI number | 3015349756 |
At a glance
- 10–99 Supplements
- May 31, 2002 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 1–9 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 PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: