SYMMETRIC TOTAL KNEE SYSTEM


Device Classification Name

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

510(k) Number K080199
Device Name SYMMETRIC TOTAL KNEE SYSTEM
Applicant
SIGNAL MEDICAL CORPORATION
1000 des peres rd.
suite 140
st. louis, 
MO 
63131

Applicant Contact brian katerberg
Correspondent
SIGNAL MEDICAL CORPORATION
1000 des peres rd.
suite 140
st. louis, 
MO 
63131

Correspodent Contact brian katerberg
Regulation Number 888.3560
Classification Product Code
JWH  
Date Received 01/25/2008
Decision Date 07/03/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No