DEPUY GLOBAL C.AP. CTA RESURFACING SHOULDER


Device Classification Name

prosthesis, shoulder, hemi-, humeral, metallic uncemented

510(k) Number K080990
Device Name DEPUY GLOBAL C.AP. CTA RESURFACING SHOULDER
Applicant
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw, 
IN 
46581 -0988

Applicant Contact dawn sinclair
Correspondent
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw, 
IN 
46581 -0988

Correspodent Contact dawn sinclair
Regulation Number 888.3690
Classification Product Code
HSD  
Date Received 04/07/2008
Decision Date 08/08/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No