The following data is part of a premarket notification filed by Bonesupport Ab with the FDA for Cerament Bone Void Filler, Model A0210.
| Device ID | K073316 |
| 510k Number | K073316 |
| Device Name: | CERAMENT BONE VOID FILLER, MODEL A0210 |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | BONESUPPORT AB SCHEELEVAGEN 19A IDEON SCIENCE PARK Lund, SE Se 223-70 |
| Contact | Ann-christine Provoost |
| Correspondent | Ann-christine Provoost BONESUPPORT AB SCHEELEVAGEN 19A 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 | 2007-11-26 |
| Decision Date | 2008-06-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350055430066 | K073316 | 000 |
| 07350055430042 | K073316 | 000 |
| 07350055430035 | K073316 | 000 |