DEPUY CTA REVERSE SHOULDER SYSTEM


Device Classification Name

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

510(k) Number K122442
Device Name DEPUY CTA REVERSE SHOULDER SYSTEM
Applicant
DEPUY FRANCE
700 orthopaedic drive
warsaw, 
IN 
46580

Applicant Contact megan burns
Correspondent
DEPUY FRANCE
700 orthopaedic drive
warsaw, 
IN 
46580

Correspodent Contact megan burns
Regulation Number 888.3660
Classification Product Code
KWS  
Date Received 08/10/2012
Decision Date 09/06/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No