The following data is part of a premarket notification filed by Innovative Surgical Designs with the FDA for True Spinal Fixation System.
| Device ID | K130958 |
| 510k Number | K130958 |
| Device Name: | TRUE SPINAL FIXATION SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | INNOVATIVE SURGICAL DESIGNS 2660 E. 2ND STREET #10 Bloomington, IN 47401 |
| Contact | Ed Morris |
| Correspondent | Ed Morris INNOVATIVE SURGICAL DESIGNS 2660 E. 2ND STREET #10 Bloomington, IN 47401 |
| Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-05 |
| Decision Date | 2013-10-17 |
| Summary: | summary |