FDA 510(k) Applications for Medical Device Product Code "HSH"
(Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented))

FDA 510(k) Number Applicant Device Name Decision Date
K073233 ADVANCED BIO-SURFACES, INC. ORTHOGLIDE LATERAL KNEE IMPLANT AND INSTRUMENTS 01/28/2008
K053094 ADVANCED BIO-SURFACES, INC. ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056 02/06/2006
K033242 IMAGING THERAPEUTICS, INC. KNEE INTERPOSITIONAL MINI-REPAIR SYSTEM (KIMRS) 12/31/2003
K022779 OSTEOIMPLANT TECHNOLOGY, INC. OTI UNICONDULAR INTERPOSITIONAL SPACER 11/20/2002
K003269 SULZER ORTHOPEDICS, INC. UNICONDYLAR INTERPOSITIONAL SPACER 01/04/2001


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