The following data is part of a premarket notification filed by Isotis Nv with the FDA for Ossatura Bcp Bone Void Filler.
| Device ID | K030131 |
| 510k Number | K030131 |
| Device Name: | OSSATURA BCP BONE VOID FILLER |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | ISOTIS NV 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Mary Mcnamara-cullinane |
| Correspondent | Mary Mcnamara-cullinane ISOTIS NV 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-14 |
| Decision Date | 2003-05-20 |
| Summary: | summary |