The following data is part of a premarket notification filed by Orthopaedic Implant Company with the FDA for Drpx Locking Distal Radius Plate System.
| Device ID | K202971 |
| 510k Number | K202971 |
| Device Name: | DRPx Locking Distal Radius Plate System |
| Classification | Plate, Fixation, Bone |
| Applicant | Orthopaedic Implant Company 770 Smithridge Dr. #400 Reno, NV 89502 |
| Contact | Douglas Fulton |
| Correspondent | Douglas Fulton Orthopaedic Implant Company 770 Smithridge Dr. #400 Reno, NV 89502 |
| Product Code | HRS |
| Subsequent Product Code | HTN |
| Subsequent Product Code | HWC |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-30 |
| Decision Date | 2021-05-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10811998039463 | K202971 | 000 |
| 10811998039777 | K202971 | 000 |
| 10811998039760 | K202971 | 000 |
| 10811998035755 | K202971 | 000 |
| 10811998035748 | K202971 | 000 |
| 10811998039739 | K202971 | 000 |