KINEMATIC II ROTATING HINGE KNEE


Device Classification Name

prosthesis, knee, femorotibial, semi-constrained, cemented, trunnion-bearing

510(k) Number K992346
Device Name KINEMATIC II ROTATING HINGE KNEE
Applicant
HOWMEDICA OSTEONICS CORP.
59 route 17 south
allendale, 
NJ 
07401 -1677

Applicant Contact karen ariemma
Correspondent
HOWMEDICA OSTEONICS CORP.
59 route 17 south
allendale, 
NJ 
07401 -1677

Correspodent Contact karen ariemma
Regulation Number 888.3530
Classification Product Code
LGE  
Subsequent Product Code
KRO  
Date Received 07/13/1999
Decision Date 08/12/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No