The following data is part of a premarket notification filed by Bacterin International Inc. with the FDA for Osteoselect Plus Demineralized Bone Matrix Putty.
| Device ID | K150621 |
| 510k Number | K150621 |
| Device Name: | OsteoSelect PLUS Demineralized Bone Matrix Putty |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | BACTERIN INTERNATIONAL INC. 600 Cruiser Ln Belgrade, MT 59714 |
| Contact | Howard L Schrayer |
| Correspondent | Howard L 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 | 2015-03-11 |
| Decision Date | 2015-08-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849777009157 | K150621 | 000 |
| 00889795113290 | K150621 | 000 |
| 00889795113283 | K150621 | 000 |
| 00889795113276 | K150621 | 000 |
| 00849777011686 | K150621 | 000 |
| 00849777011679 | K150621 | 000 |
| 00849777011662 | K150621 | 000 |
| 00849777011761 | K150621 | 000 |
| 00849777011754 | K150621 | 000 |
| 00849777011747 | K150621 | 000 |
| 00849777011938 | K150621 | 000 |
| 00849777011921 | K150621 | 000 |
| 00849777011914 | K150621 | 000 |
| 00849777012300 | K150621 | 000 |
| 00849777012294 | K150621 | 000 |
| 00849777004978 | K150621 | 000 |
| 00849777006699 | K150621 | 000 |
| 00849777006705 | K150621 | 000 |
| 00849777008822 | K150621 | 000 |
| 00849777008815 | K150621 | 000 |
| 00849777008808 | K150621 | 000 |
| 00849777008495 | K150621 | 000 |
| 00849777008488 | K150621 | 000 |
| 00849777008358 | K150621 | 000 |
| 00849777008341 | K150621 | 000 |
| 00849777008334 | K150621 | 000 |
| 00849777008327 | K150621 | 000 |
| 00849777008310 | K150621 | 000 |
| 00849777008303 | K150621 | 000 |
| 00849777006736 | K150621 | 000 |
| 00849777006729 | K150621 | 000 |
| 00849777006712 | K150621 | 000 |
| 00849777012287 | K150621 | 000 |