ADVANCE A-CLASS TIBIAL INSERT


Device Classification Name

prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer

510(k) Number K081479
Device Name ADVANCE A-CLASS TIBIAL INSERT
Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 airline rd.
arlington, 
TN 
38002

Applicant Contact fred w bowman
Correspondent
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 airline rd.
arlington, 
TN 
38002

Correspodent Contact fred w bowman
Regulation Number 888.3565
Classification Product Code
MBH  
Subsequent Product Code
JWH  
Date Received 05/27/2008
Decision Date 02/20/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No