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KWI — Prosthesis, Elbow, Hemi-, Radial, Polymer Class II

FDA Device Classification

Classification Details

Product Code
KWI
Device Class
Class II
Regulation Number
888.3170
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K233592biopolyBioPoly Radial Head ImplantMarch 13, 2024
K231188skeletal dynamicsALIGN Radial Head SystemSeptember 28, 2023
K213563depuy synthesDePuy Synthes Radial Head Replacement SystemMarch 18, 2022
K212872in2bones usaAvenger Radial Head SystemDecember 17, 2021
K192754in2bones usaAvenger Radial Head SystemJanuary 7, 2020
K183618ignite orthopedicsRevolution Radial HeadMay 17, 2019
K172688skeletal dynamicsAlign Radial Head SystemDecember 22, 2017
K132735imds (innovative medical device systems) - leis meAXIA RADIAL HEAD SYSTEMJanuary 7, 2014
K131845acumedACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMSeptember 30, 2013
K112030synthes usaSYNTHES RADIAL HEAD PROSTHESIS SYSTEMJune 19, 2012
K092721skeletal dynamicsALIGN RADIAL HEAD SYSTEMAugust 3, 2010
K062898small bone innovationsSBI LATERAL RHEAD IMPLANTNovember 13, 2006
K060731wrightmedicaltechnologyincEVOLVE MODULAR RADIAL HEADApril 19, 2006
K051385biometEXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICEAugust 5, 2005
K041858acumedACUMED ANATOMIC RADIAL HEAD SYSTEMOctober 5, 2004
K040611biometMODULAR RADIAL HEAD REPLACEMENT DEVICEJune 4, 2004
K032806kinetikos medicalKATALYST RADIAL HEAD IMPLANTApril 16, 2004
K032686ascension orthopedicsASCENSION MODULAR RADIAL HEADOctober 22, 2003
K030237kapp surgical instrumentKAPP CUSTOM RADIAL HEAD ELBOW IMPLANTAugust 29, 2003
K030384wrightmedicaltechnologyincEVOLVE CERAMIC RADIAL HEAD IMPLANTAugust 12, 2003