The following data is part of a premarket notification filed by Isotis Nv with the FDA for Orthoblast Ii Dbm Demineralized Bone Matrix Paste And Putty.
| Device ID | K060332 |
| 510k Number | K060332 |
| Device Name: | ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY |
| Classification | Bone Grafting Material, Human Source |
| Applicant | ISOTIS NV PROF. BRONKHORSTLAAN 10-D Bilthoven, NL 3723 Mb |
| Contact | Eliane Schutte |
| Correspondent | Eliane Schutte ISOTIS NV PROF. BRONKHORSTLAAN 10-D Bilthoven, NL 3723 Mb |
| Product Code | NUN |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-09 |
| Decision Date | 2006-03-29 |
| Summary: | summary |