DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM


Device Classification Name

prosthesis, hip, semi-constrained (metal uncemented acetabular component)

510(k) Number K080991
Device Name DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM
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 888.3330
Classification Product Code
KWA  
Date Received 04/07/2008
Decision Date 07/02/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls