FANNING-PAPPAS MODULAR KNEE BEARING


Device Classification Name

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

510(k) Number K081400
Device Name FANNING-PAPPAS MODULAR KNEE BEARING
Applicant
ENDOTEC, INC.
2546 hansrob rd.
orlando, 
FL 
32804

Applicant Contact michael pappas
Correspondent
ENDOTEC, INC.
2546 hansrob rd.
orlando, 
FL 
32804

Correspodent Contact michael pappas
Regulation Number 888.3560
Classification Product Code
JWH  
Date Received 05/19/2008
Decision Date 02/20/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No