The following data is part of a premarket notification filed by Isotis Orthobiologics, Inc with the FDA for Orthoblast Ii Dbm Demineralized Bone Matrix Paste And Putty.
| Device ID | K070751 |
| 510k Number | K070751 |
| Device Name: | ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | ISOTIS ORTHOBIOLOGICS, INC 2 GOODYEAR, SUITE B Irvine, CA 92618 |
| Contact | Karon Morell |
| Correspondent | Karon Morell ISOTIS ORTHOBIOLOGICS, INC 2 GOODYEAR, SUITE B Irvine, CA 92618 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-19 |
| Decision Date | 2007-10-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889981153694 | K070751 | 000 |
| 10889981153687 | K070751 | 000 |
| 10889981153670 | K070751 | 000 |
| 10889981153663 | K070751 | 000 |
| 10889981153656 | K070751 | 000 |