OTI UNICONDULAR INTERPOSITIONAL SPACER


Device Classification Name

prosthesis, knee, hemi-, tibial, resurfacing (uncemented)

510(k) Number K022779
Device Name OTI UNICONDULAR INTERPOSITIONAL SPACER
Original Applicant
OSTEOIMPLANT TECHNOLOGY, INC.
11201 pepper rd.
hunt valley, 
MD 
21031 -1201

Original Contact sam son
Regulation Number 888.3590
Classification Product Code
HSH  
Date Received 08/22/2002
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