PROVEN STEM EXTENDER


Device Classification Name

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

510(k) Number K081458
Device Name PROVEN STEM EXTENDER
Applicant
STELKAST COMPANY
200 hidden valley rd.
mcmurray, 
PA 
15317

Applicant Contact donald a stevens
Correspondent
STELKAST COMPANY
200 hidden valley rd.
mcmurray, 
PA 
15317

Correspodent Contact donald a stevens
Regulation Number 888.3560
Classification Product Code
JWH  
Date Received 05/23/2008
Decision Date 06/06/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No