The following data is part of a premarket notification filed by Field Orthopaedics Pty Ltd with the FDA for Field Orthopaedics Bony Trauma Extremity System (btes) Plate Range And Plate Screws; Field Orthopaedics Bony Trauma Extremity System (btes) Screw Range.
| Device ID | K200043 |
| 510k Number | K200043 |
| Device Name: | Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range And Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range |
| Classification | Plate, Fixation, Bone |
| Applicant | Field Orthopaedics Pty Ltd 375 Wickham Terrace Spring Hill, AU 4000 |
| Contact | Kieran Leacy |
| Correspondent | Kieran Leacy Field Orthopaedics Pty Ltd 375 Wickham Terrace Spring Hill, AU 4000 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-08 |
| Decision Date | 2020-03-23 |