The following data is part of a premarket notification filed by Orthospin Ltd with the FDA for Autostrut G2.
| Device ID | K202810 |
| 510k Number | K202810 |
| Device Name: | AutoStrut G2 |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | OrthoSpin Ltd 13 Hayezira St. Yokneam, IL 2066720 |
| Contact | Oren Cohen |
| Correspondent | Janice Hogan Hogan Lovells US LLP 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 | 2020-09-23 |
| Decision Date | 2021-01-06 |