The following data is part of a premarket notification filed by Fournitures Hospitalieres Industrie with the FDA for Calcanail Orthopedic Arthrodesis Nail.
| Device ID | K150471 |
| 510k Number | K150471 |
| Device Name: | CalcaNail Orthopedic Arthrodesis Nail |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | Fournitures Hospitalieres Industrie ZI De Kernevez – 6 Rue Nobel Quimper, FR 29000 |
| Contact | Patricia Donnard |
| Correspondent | Patricia Donnard Fournitures Hospitalieres Industrie ZI De Kernevez ? 6 Rue Nobel Quimper, FR 29000 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-23 |
| Decision Date | 2015-05-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03661489683169 | K150471 | 000 |
| 03661489683152 | K150471 | 000 |
| 03661489683145 | K150471 | 000 |