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KTW — Appliance, Fixation, Nail/Blade/Plate Combination, Single Component Class II

FDA Device Classification

Classification Details

Product Code
KTW
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
K182285paonan biotech coPK High Tibial Osteotomy Correction SystemJune 20, 2019
K171606advanced orthopaedic solutions, inc. (aos)AOS Anterolateral Proximal Humeral PlateJune 22, 2017
K170693paragon 28Phantom Small Bone Intramedullary Nail SystemJune 19, 2017
K160409advanced orthopaedic solutionsAOS Anterolateral Proximal Humeral PlateMarch 15, 2016
K122541orthofixORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP)September 20, 2012
K080590advanced orthopaedic solutionsAOS PROXIMAL HUMERAL PLATEMay 6, 2008
K080109synthes (usa)SYNTHES (USA) MODULAR BLADE PLATE SYSTEMMarch 20, 2008
K062920orthofixORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSPNovember 13, 2006
K023360jeil medical corporationLEFORTE SYSTEM BONE PLATEOctober 25, 2002
K012645alliance medicalREPROCESSED EBI EXTERNAL FIXATION DEVICESJune 24, 2002
K012634alliance medicalREPROCESSED EXTERNAL FIXATION DEVICEJune 24, 2002
K011815synthes (usa)SYNTHES LCP PROXIMAL HUMERUS PLATESSeptember 6, 2001
K011458synthes (usa)SYNTHES STRAIGHT WRIST FUSION PLATE, 170MMAugust 2, 2001
K010321synthes (usa)MODULAR FOOT SYSTEM - 2.7 MM MODULEMay 2, 2001
K001614howmedica osteonicsSTRYKER TRAUMA PELVIC SETAugust 4, 2000
K001271biometSAMARCO SPIDER PLATESJuly 14, 2000
K992837synthes (usa)3.5 MM 90 CANNULATED LIMITED CONTACT ANGELED BLADE PLATES (3.5MM 90 CANNULATED LOctober 25, 1999
K991405turnkey intergration usaOMNI-FIX, HUMERAL NAILJune 29, 1999
K990307turnkey intergration usaOMNI-FIX, NAIL SYSTEMApril 1, 1999
K982390wrightmedicaltechnologyincCONCISE COMPRESSION HIP SCREW SYSTEM (STERILE)September 14, 1998