PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT


the company

Device Classification Name

prosthesis, hip, femoral component, cemented, metal

510(k) Number K001984
Device Name PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT
Original Applicant
STELKAST COMPANY
800 vinial st. #210
pittsburgh, 
PA 
15212

Original Contact donald a stevens
Regulation Number 888.3360
Classification Product Code
JDG  
Date Received 06/29/2000
Decision Date 09/27/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No