The following data is part of a premarket notification filed by Biologically Oriented Prostheses with the FDA for Wujin #3 Tibial Nail.
| Device ID | K002325 |
| 510k Number | K002325 |
| Device Name: | WUJIN #3 TIBIAL NAIL |
| Classification | Nail, Fixation, Bone |
| Applicant | BIOLOGICALLY ORIENTED PROSTHESES 17 SEVENTEENTH ST. Port Huron, MI 48060 |
| Contact | Angena Parekh |
| Correspondent | Angena Parekh BIOLOGICALLY ORIENTED PROSTHESES 17 SEVENTEENTH ST. Port Huron, MI 48060 |
| Product Code | JDS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-01 |
| Decision Date | 2000-10-30 |