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 |