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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)
510(k) Number K022779
Device Name OTI UNICONDULAR INTERPOSITIONAL SPACER
Applicant
OSTEOIMPLANT TECHNOLOGY, INC.
11201 PEPPER RD.
HUNT VALLEY,  MD  21031 -1201
Applicant Contact SAM SON
Correspondent
OSTEOIMPLANT TECHNOLOGY, INC.
11201 PEPPER RD.
HUNT VALLEY,  MD  21031 -1201
Correspondent Contact SAM SON
Regulation Number888.3590
Classification Product Code
HSH  
Date Received08/22/2002
Decision Date 11/20/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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