The following data is part of a premarket notification filed by Bacterin International Inc. with the FDA for Osteoselect Demineralized Bone Matrix Putty.
| Device ID | K091321 |
| 510k Number | K091321 |
| Device Name: | OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | BACTERIN INTERNATIONAL INC. 600 CRUISER LN. Belgrade, MT 59714 |
| Contact | Howard J Schrayer |
| Correspondent | Howard J Schrayer BACTERIN INTERNATIONAL INC. 600 CRUISER LN. Belgrade, MT 59714 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-05 |
| Decision Date | 2009-09-11 |
| Summary: | summary |