The following data is part of a premarket notification filed by Orthospin with the FDA for Autostrut.
| Device ID | K191241 |
| 510k Number | K191241 |
| Device Name: | AutoStrut |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | OrthoSpin 17 Hatechelet Street Misgav, IL 2017400 |
| Contact | Oren Cohen |
| Correspondent | Janice M. Hogan Hogan Lovells US LPP 1735 Market Street Suite 2300 Philadelphia, PA 19103 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-08 |
| Decision Date | 2019-08-14 |