DELTA SHOULDER


Device Classification Name

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

510(k) Number K021478
Device Name DELTA SHOULDER
Original Applicant
DEPUY, INC.
700 orthopaedic dr.
warsaw, 
IN 
46581 -0988

Original Contact janet g johnson
Regulation Number 888.3660
Classification Product Code
KWS  
Date Received 05/08/2002
Decision Date 11/18/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No