The following data is part of a premarket notification filed by Wishbone Medical, Inc. with the FDA for Wishbone Medical Plate And Screw System.
| Device ID | K203467 |
| 510k Number | K203467 |
| Device Name: | WishBone Medical Plate And Screw System |
| Classification | Screw, Fixation, Bone |
| Applicant | WishBone Medical, Inc. 100 Capital Drive Warsaw, IN 46582 |
| Contact | Mary Wentorf |
| Correspondent | Mary Wentorf WishBone Medical, Inc. 100 Capital Drive Warsaw, IN 46582 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-25 |
| Decision Date | 2020-12-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B56251201WR0070T10 | K203467 | 000 |
| B56251201WR0070T00 | K203467 | 000 |