The following data is part of a premarket notification filed by Biomet Osteobiologics with the FDA for Boneplast Qs Calcium Sulfate Bone Void Filler.
| Device ID | K070864 |
| 510k Number | K070864 |
| Device Name: | BONEPLAST QS CALCIUM SULFATE BONE VOID FILLER |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | BIOMET OSTEOBIOLOGICS P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Palaniswamy Vijay |
| Correspondent | Palaniswamy Vijay BIOMET OSTEOBIOLOGICS P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-28 |
| Decision Date | 2007-06-01 |
| Summary: | summary |