AESCULAP IMPLANT SYSTEMS HIGH TIBIAL OSTEOTOMY PLATING SYSTEM


Device Classification Name

plate, fixation, bone

510(k) Number K080992
Device Name AESCULAP IMPLANT SYSTEMS HIGH TIBIAL OSTEOTOMY PLATING SYSTEM
Applicant
AESCULAP IMPLANT SYSTEMS, INC.
3773 corporate pkwy.
center valley, 
PA 
18034

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

Correspodent Contact lisa boyle
Regulation Number 888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received 04/07/2008
Decision Date 09/04/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No