JDS — Nail, Fixation, Bone

Class 2 Implant

Medical Specialty

Review Panel

Submission Type

FDA Authorisations (53)

Device Name	Manufacturer	K-Number	Decision Date
TRIGEN Stable Lock Nut & Washer	Smith & Nephew, Inc.	K243608	2025-06-12
TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System	Smith & Nephew, Inc.	K240061	2024-09-20
TRIGEN INTERTAN 10S Nail System	Smith & Nephew, Inc.	K241804	2024-08-22
NET BRAND Osteosynthesis Nailing System	Narang Medical , Ltd.	K233150	2024-02-20
TRIGEN META-NAIL Nail System	Smith & Nephew, Inc.	K230761	2023-06-14
DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm	Synthes (USA) Products, LLC	K201336	2020-09-03
Auxein Nailing System	Auxein Medical Private Limited	K192003	2020-06-10
WIN Flexible Nail System	Biomet, Inc.	K193533	2020-02-20
CONVENTUS PHS SYSTEM	Conventus Orthopaedics, Inc.	K141737	2015-04-08
CHINA NAILS AND ACCESSORIES	Smith & Nephew, Inc.	K123948	2013-03-14
SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS	Synthes (Usa)	K111667	2011-12-05
CONNEXX LOCKING TIBIA NAIL	I.T.S. Implantat-Technologie-Systeme GmbH	K080706	2008-06-09
SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS	Synthes (Usa)	K072095	2007-09-27
SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM	Synthes (Usa)	K062872	2007-03-13
KNEE FUSION NAIL	Smith & Nephew, Inc.	K061783	2006-08-10
TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS	Smith & Nephew, Inc.	K061019	2006-06-06
TRIGEN RETROGRADE FEMORAL, SUPRACONDYLAR AND TIBIAL NAILS	Smith & Nephew, Inc.	K051557	2005-06-30
KNEE FUSION NAIL	Smith & Nephew, Inc.	K050938	2005-05-04
SYNTHES (USA) TIBIAL NAIL SYSTEM EX	Synthes (Usa)	K040762	2004-04-12
TRIGEN INTERTAN	Smith & Nephew, Inc.	K040212	2004-02-20

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