STELKAST PROVEN KNEE SYSTEM


Device Classification Name

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

510(k) Number K002281
Device Name STELKAST PROVEN KNEE SYSTEM
Original Applicant
STELKAST COMPANY
800 vinial st.
suite b-210
pittsburgh, 
PA 
15212

Original Contact donald a stevens
Regulation Number 888.3560
Classification Product Code
JWH  
Date Received 07/24/2000
Decision Date 08/17/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls