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510(k) K201336

Device
DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 And 5.0mm
Applicant
Synthes (USA) Products, LLC
510(k) number
K201336
Product code
JDS  
Decision
Substantially Equivalent (SESE)
Decision date
2020-09-03
Date received
2020-05-20
Regulation
888.3030
Classification name
Nail, Fixation, Bone
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Pol Fort Grebol
Address
1301 Goshen Pkwy. West Chester PA US 19380 19380

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JDS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243608TRIGEN Stable Lock Nut & WasherSmith & Nephew, Inc.2025-06-12
K240061TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail SystemSmith & Nephew, Inc.2024-09-20
K241804TRIGEN INTERTAN 10S Nail SystemSmith & Nephew, Inc.2024-08-22
K233150NET BRAND Osteosynthesis Nailing SystemNarang Medical , Ltd.2024-02-20
K230761TRIGEN META-NAIL Nail SystemSmith & Nephew, Inc.2023-06-14
K192003Auxein Nailing SystemAuxein Medical Private Limited2020-06-10
K193533WIN Flexible Nail SystemBiomet, Inc.2020-02-20
K141737CONVENTUS PHS SYSTEMConventus Orthopaedics, Inc.2015-04-08
K123948CHINA NAILS AND ACCESSORIESSmith & Nephew, Inc.2013-03-14
K111667SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTSSynthes (Usa)2011-12-05
K080706CONNEXX LOCKING TIBIA NAILI.T.S. Implantat-Technologie-Systeme GmbH2008-06-09
K072095SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONSSynthes (Usa)2007-09-27
K062872SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEMSynthes (Usa)2007-03-13
K061783KNEE FUSION NAILSmith & Nephew, Inc.2006-08-10
K061019TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILSSmith & Nephew, Inc.2006-06-06

Legacy Summary#

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FDA Review#

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