The following data is part of a premarket notification filed by Biomatlante with the FDA for Tribone 80.
| Device ID | K071121 |
| 510k Number | K071121 |
| Device Name: | TRIBONE 80 |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | BIOMATLANTE 5, RUE EDOUARD BELIN Vigneux De Bretagne, FR 44360 |
| Contact | Adeline Filliatre |
| Correspondent | Adeline Filliatre BIOMATLANTE 5, RUE EDOUARD BELIN Vigneux De Bretagne, FR 44360 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-20 |
| Decision Date | 2007-09-11 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() TRIBONE 80 76457654 2842341 Dead/Cancelled |
BIOMATLANTE 2002-10-04 |