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JDS — Nail, Fixation, Bone Class II

FDA Device Classification

Classification Details

Product Code
JDS
Device Class
Class II
Regulation Number
888.3030
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K243608smith and nephewTRIGEN Stable Lock Nut & WasherJune 12, 2025
K240061smith and nephewTRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail SystemSeptember 20, 2024
K241804smith and nephewTRIGEN INTERTAN 10S Nail SystemAugust 22, 2024
K233150narang medicalNET BRAND Osteosynthesis Nailing SystemFebruary 20, 2024
K230761smith and nephewTRIGEN META-NAIL Nail SystemJune 14, 2023
K201336synthes (usa) productsDePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary NailsSeptember 3, 2020
K192003auxein medical private limitedAuxein Nailing SystemJune 10, 2020
K193533biometWIN Flexible Nail SystemFebruary 20, 2020
K141737conventus orthopaedicsCONVENTUS PHS SYSTEMApril 8, 2015
K123948smith and nephewCHINA NAILS AND ACCESSORIESMarch 14, 2013
K111667synthes (usa)SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTSDecember 5, 2011
K080706i.t.s. implantat-technologie-systemeCONNEXX LOCKING TIBIA NAILJune 9, 2008
K072095synthes (usa)SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONSSeptember 27, 2007
K062872synthes (usa)SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEMMarch 13, 2007
K061783smith and nephewKNEE FUSION NAILAugust 10, 2006
K061019smith and nephewTRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILSJune 6, 2006
K051557smith and nephewTRIGEN RETROGRADE FEMORAL, SUPRACONDYLAR AND TIBIAL NAILSJune 30, 2005
K050938smith and nephewKNEE FUSION NAILMay 4, 2005
K040762synthes (usa)SYNTHES (USA) TIBIAL NAIL SYSTEM EXApril 12, 2004
K040212smith and nephewTRIGEN INTERTANFebruary 20, 2004