The following data is part of a premarket notification filed by 4web Medical, Inc. with the FDA for Osteotomy Truss System (ots).
| Device ID | K220463 |
| 510k Number | K220463 |
| Device Name: | Osteotomy Truss System (OTS) |
| Classification | Plate, Fixation, Bone |
| Applicant | 4WEB Medical, Inc. 2801 Network Blvd., Suite 620 Frisco, TX 75034 |
| Contact | Lewis Harrison |
| Correspondent | Richard Jansen Silver Pine Consulting 3851 Mossy Oak Drive Fort Myers, FL 33905 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-17 |
| Decision Date | 2022-05-18 |