FDA 510(k) Applications Submitted by SMITH & NEPHEW INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K240381 |
02/08/2024 |
CATALYSTEM Femoral Stems |
Smith & Nephew Inc. |
| K250571 |
02/26/2025 |
CATALYSTEM Femoral Stems |
Smith & Nephew Inc. |
| K233396 |
10/03/2023 |
Cannulated Screw System |
Smith & Nephew Inc. |
| K230761 |
03/20/2023 |
TRIGEN META-NAIL Nail System |
Smith & Nephew Inc. |
| K241804 |
06/21/2024 |
TRIGEN INTERTAN 10S Nail System |
Smith & Nephew Inc. |
| K162303 |
08/17/2016 |
REDAPT Sleeved Monolithic Revision Stems |
SMITH & NEPHEW INC. |
| K231376 |
05/12/2023 |
Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape) |
Smith & Nephew Inc. |
| K213126 |
09/27/2021 |
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 |
Smith & Nephew Inc. |
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