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510(k) K914453

Device
UNIVERSAL TIBIAL NAIL AND UNREAMED TIBIAL NAIL
Applicant
SYNTHES (USA)
510(k) number
K914453
Product code
JDS  
Decision
Substantially Equivalent (SESE)
Decision date
1992-02-18
Date received
1991-10-04
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
DIANE COCHET-WYNANT
Address
1690 Russell Rd. Post Office Box 1766 Paoli PA US 19301 19301

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
K201336DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mmSynthes (USA) Products, LLC2020-09-03
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

Legacy Summary#

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FDA Review#

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