The following data is part of a premarket notification filed by Wishbone Medical, Inc. with the FDA for Wishbone Medical Plate And Screw System: 3.0mm Screws And 7-hole Straight Fibula Plate.
| Device ID | K213489 |
| 510k Number | K213489 |
| Device Name: | Wishbone Medical Plate And Screw System: 3.0mm Screws And 7-Hole Straight Fibula Plate |
| Classification | Plate, Fixation, Bone |
| Applicant | WishBone Medical, Inc. 100 Capital Drive Warsaw, IN 46582 |
| Contact | Ramakrishna Bajaj |
| Correspondent | Ramakrishna Bajaj WishBone Medical, Inc. 100 Capital Drive Warsaw, IN 46582 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-01 |
| Decision Date | 2022-01-27 |