GLOBAL ADVANTAGE EXTENDED HUMERAL HEAD


definition

Device Classification Name

prosthesis, shoulder, semi-constrained, metal/polymer cemented

510(k) Number K000575
Device Name GLOBAL ADVANTAGE EXTENDED HUMERAL HEAD
Original Applicant
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw, 
IN 
46581 -0988

Original Contact marcia j arentz
Regulation Number 888.3660
Classification Product Code
KWS  
Subsequent Product Code
HSD  
Date Received 02/22/2000
Decision Date 03/10/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

Type Traditional
Reviewed by Third Party No

Combination Product

No