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KWA — Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) Class III

FDA Device Classification

Classification Details

Product Code
KWA
Device Class
Class III
Regulation Number
888.3330
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K122778wrightmedicaltechnologyincPROFEMUR Z REVISION HIP STEMOctober 11, 2012
K121544wrightmedicaltechnologyincDYNASTY BIOFOAM SHELLJuly 30, 2012
K113271biomet manufacturingMETAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONSMay 18, 2012
K113322wrightmedicaltechnologyincCONSERVE THIN SHELLFebruary 3, 2012
K112080wrightmedicaltechnologyincPRESERVE HIP STEMDecember 28, 2011
K112150wrightmedicaltechnologyincPROFEMUR GLADIATOR HA HIP STEMNovember 23, 2011
K113019wrightmedicaltechnologyincPROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZERNovember 10, 2011
K111910wrightmedicaltechnologyincGLADIATOR HIP STEMOctober 14, 2011
K110836zimmerCLS BREVIUS STEM WITH KINECTIV TECHNOLOGYOctober 7, 2011
K110400biomet manufacturingTAPERLOC COMPLETE MICROPLASTY STEMSeptember 30, 2011
K111699wrightmedicaltechnologyincPROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEMAugust 19, 2011
K111698wrightmedicaltechnologyincPROFEMUR(R) E CEMENTLESS HIP STEMAugust 19, 2011
K110399wrightmedicaltechnologyincGLADIATOR PLASMA CLASSIC HIP STEMMay 10, 2011
K110029wrightmedicaltechnologyincCONSERVE BIO FOAM SHELLApril 19, 2011
K103755biomet manufacturingTAPERLOC COMPLETE, SIZE 5 AND 6January 21, 2011
K102565wrightmedicaltechnologyincANTERIOR APPROACH HIP SURGERY INSTRUMENTSDecember 22, 2010
K100469biomet manufacturingARCOS INTERLOCKING DISTAL STEMSDecember 7, 2010
K101086biometTAPERLOC COMPLETESeptember 3, 2010
K101475biomet manufacturingCOMPRESS ANTI-ROTATION SPINDLESJune 18, 2010
K093235biometRINGLOC + HYBRID ACETABULAR SYSTEMApril 30, 2010