The following data is part of a premarket notification filed by Bonesupport Ab with the FDA for Cerament Bone Void Filler.
| Device ID | K201535 |
| 510k Number | K201535 |
| Device Name: | Cerament Bone Void Filler |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | BoneSupport AB Scheelevagen 19, Ideon Science Park Lund, SE Se 223-70 |
| Contact | Blerta Shuka |
| Correspondent | Blerta Shuka BoneSupport AB Scheelevagen 19, Ideon Science Park Lund, SE Se 223-70 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-08 |
| Decision Date | 2020-10-16 |