The following data is part of a premarket notification filed by Smith & Nephew Inc. with the FDA for Smith & Nephew, Inc. Plates And Screws Systems: Evos, Peri-loc, D-rad, Tc-100, Vlp Mini-mod, Compression Hip Screw (chs), Conquest Fn, And Cannulated Screws.
| Device ID | K213126 |
| 510k Number | K213126 |
| Device Name: | Smith & Nephew, Inc. Plates And Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, And Cannulated Screws |
| Classification | Device, Fixation, Proximal Femoral, Implant |
| Applicant | Smith & Nephew Inc. 1450 E Brooks Rd Memphis, TN 38116 |
| Contact | Thomas Fearnley |
| Correspondent | Rose Beifuss Smith & Nephew Inc. 1450 E Brooks Rd Memphis, TN 38116 |
| Product Code | JDO |
| Subsequent Product Code | HRS |
| Subsequent Product Code | HTN |
| Subsequent Product Code | HTY |
| Subsequent Product Code | HWC |
| Subsequent Product Code | KTT |
| Subsequent Product Code | NDG |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-27 |
| Decision Date | 2022-09-29 |