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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