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Smith & Nephew, Inc.

FDA 510(k) & PMA Approved Devices — 509 products

Total Devices509
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K261462 LANDMARK Total Knee SystemMBH2026-09-08 View
510(k) K261968 Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)MBI2026-07-09 View
510(k) K254084 AETOS Shoulder System - CONCELOC GlenoidsKWS2026-04-06 View
510(k) K252416 AETOS Shoulder System Meta Humeral Prosthesis Size 0KWS2025-10-29 View
510(k) K252129 AETOS Shoulder System Stemless Humeral ProsthesisPKC2025-10-03 View
510(k) K251627 BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue)MBI2025-06-25 View
510(k) K243608 TRIGEN Stable Lock Nut & WasherJDS2025-06-12 View
510(k) K250677 LEGION Total Knee SystemJWH2025-04-02 View
510(k) K250571 CATALYSTEM Femoral StemsLZO2025-03-28 View
510(k) K243364 TRIGEN META-TAN Trochanteric Antegrade NailHSB2024-12-09 View
510(k) K240716 AETOS Shoulder System Stemless Humeral ProsthesisPKC2024-11-20 View
510(k) K242711 JOURNEY II Unicompartmental Knee System (JOURNEY II UK)HSX2024-10-30 View
510(k) K240783 Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip StemsJDI2024-10-21 View
510(k) K242375 OR3O Dual Mobility SystemLPH2024-10-07 View
510(k) K240061 TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail SystemJDS2024-09-20 View
510(k) K241804 TRIGEN INTERTAN 10S Nail SystemJDS2024-08-22 View
510(k) K240381 CATALYSTEM Femoral StemsLZO2024-06-27 View
510(k) K241435 Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, co-braid-blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, co-braid-blueMBI2024-06-20 View
510(k) K240113 CORIOGRAPH Knee Pre-Op PlanPBF2024-03-18 View
510(k) K233949 ACCORD Cable SystemJDQ2024-03-13 View
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