The following data is part of a premarket notification filed by Innovative Surgical Designs, Inc. with the FDA for True Tulip, True M.i.s..
| Device ID | K212627 |
| 510k Number | K212627 |
| Device Name: | True Tulip, True M.I.S. |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Innovative Surgical Designs, Inc. 3903 S. Walnut St. Bloomington, IN 47401 |
| Contact | Jon Rinehart |
| Correspondent | Jon Rinehart Innovative Surgical Designs, Inc. 3903 S. Walnut St. Bloomington, IN 47401 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-19 |
| Decision Date | 2022-02-18 |