The following data is part of a premarket notification filed by Centerpulse Spine-tech, Inc. with the FDA for Copsios Bone Void Filler (bvf).
| Device ID | K033679 |
| 510k Number | K033679 |
| Device Name: | COPSIOS BONE VOID FILLER (BVF) |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | CENTERPULSE SPINE-TECH, INC. 7375 BUSH LAKE RD. Minneapolis, MN 55439 -2027 |
| Contact | Tim Miller |
| Correspondent | Tim Miller CENTERPULSE SPINE-TECH, INC. 7375 BUSH LAKE RD. Minneapolis, MN 55439 -2027 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-24 |
| Decision Date | 2004-07-07 |
| Summary: | summary |