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Smith & Nephew, Inc.

FDA 510(k) & PMA Approved Dispositivos — 112 products

Total de dispositivos112
Categorias0
Última decisão da FDA
TipoNúmeroNome do dispositivoCódigoDataAções
510(k) K261462 LANDMARK Total Knee SystemMBH2026-09-08 Ver
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 Ver
510(k) K254084 Sistema de Ombro AETOS - CONCELOC GlenoidsKWS2026-04-06 Ver
510(k) K252416 Prótese Metacôndila AETOS Shoulder System Size 0KWS2025-10-29 Ver
510(k) K252129 Prótese de Humeral AETOS Shoulder System Sem CabeçaPKC2025-10-03 Ver
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 Ver
510(k) K243608 TRIGEN Stable Lock Nut & WasherJDS2025-06-12 Ver
510(k) K250677 LEGION Total Knee SystemJWH2025-04-02 Ver
510(k) K250571 CATALYSTEM Femoral StemsLZO2025-03-28 Ver
510(k) K243364 TRIGEN META-TAN Trochanteric Antegrade NailHSB2024-12-09 Ver
510(k) K240716 Prótese de Humeral AETOS Shoulder System Sem CabeçaPKC2024-11-20 Ver
510(k) K242711 JOURNEY II Unicompartmental Knee System (JOURNEY II UK)HSX2024-10-30 Ver
510(k) K240783 Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip StemsJDI2024-10-21 Ver
510(k) K242375 OR3O Dual Mobility SystemLPH2024-10-07 Ver
510(k) K240061 TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail SystemJDS2024-09-20 Ver
510(k) K241804 Sistema de Parafuso TRIGEN INTERTAN 10SJDS2024-08-22 Ver
510(k) K240381 CATALYSTEM Femoral StemsLZO2024-06-27 Ver
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 Ver
510(k) K240113 CORIOGRAPH Knee Pre-Op PlanPBF2024-03-18 Ver
510(k) K233949 Sistema de Cabo ACCORDJDQ2024-03-13 Ver
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