UNIVATION UNICONDYLAR KNEE SYSTEM


Device Classification Name

prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer

510(k) Number K081293
Device Name UNIVATION UNICONDYLAR KNEE SYSTEM
Applicant
AESCULAP IMPLANT SYSTEMS, INC.
3773 corporate pkwy.
center valley, 
PA 
18034

Applicant Contact lisa m boyle
Correspondent
AESCULAP IMPLANT SYSTEMS, INC.
3773 corporate pkwy.
center valley, 
PA 
18034

Correspodent Contact lisa m boyle
Regulation Number 888.3530
Classification Product Code
HRY  
Date Received 05/07/2008
Decision Date 09/22/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No