BALANCED KNEE SYSTEM REVISION OFFSET TIBIA


Device Classification Name

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

510(k) Number K103837
Device Name BALANCED KNEE SYSTEM REVISION OFFSET TIBIA
Applicant
ORTHO DEVELOPMENT
12187 s. business park dr.
draper, 
UT 
84020

Applicant Contact tom haueter
Correspondent
ORTHO DEVELOPMENT
12187 s. business park dr.
draper, 
UT 
84020

Correspodent Contact tom haueter
Regulation Number 888.3560
Classification Product Code
JWH  
Date Received 12/30/2010
Decision Date 03/24/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No