The following data is part of a premarket notification filed by Wishbone Sa with the FDA for Wishbone Ha.
| Device ID | K211551 |
| 510k Number | K211551 |
| Device Name: | Wishbone HA |
| Classification | Bone Grafting Material, Animal Source |
| Applicant | Wishbone SA 1, Rue De 1'Expansion Flemalle, BE 4400 |
| Contact | Emilie Dory |
| Correspondent | Emilie Dory Wishbone SA 1, Rue De 1'Expansion Flemalle, BE 4400 |
| Product Code | NPM |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-19 |
| Decision Date | 2021-08-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05430001477115 | K211551 | 000 |
| 05430001477108 | K211551 | 000 |
| 05430001477092 | K211551 | 000 |
| 05430001477085 | K211551 | 000 |