ASCENT KNEE REVISION FEMORAL STEM


definition

Device Classification Name

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

510(k) Number K001010
Device Name ASCENT KNEE REVISION FEMORAL STEM
Original Applicant
BIOMET, INC.
airport industrial park,
p.o.box 587
warsaw, 
IN 
46581 -0587

Original Contact tina lakin
Regulation Number 888.3560
Classification Product Code
JWH  
Date Received 03/29/2000
Decision Date 04/27/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No