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HSH — Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented) Class II

FDA Device Classification

Classification Details

Product Code
HSH
Device Class
Class II
Regulation Number
888.3590
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K073233advanced bio-surfacesORTHOGLIDE LATERAL KNEE IMPLANT AND INSTRUMENTSJanuary 28, 2008
K053094advanced bio-surfacesORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, February 6, 2006
K033242imaging therapeuticsKNEE INTERPOSITIONAL MINI-REPAIR SYSTEM (KIMRS)December 31, 2003
K022779osteoimplant technologyOTI UNICONDULAR INTERPOSITIONAL SPACERNovember 20, 2002
K003269sulzer orthopedicsUNICONDYLAR INTERPOSITIONAL SPACERJanuary 4, 2001