MDF REVISION HIP SYSTEM


Device Classification Name

prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

510(k) Number K081124
Device Name MDF REVISION HIP SYSTEM
Applicant
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis, 
TN 
38116

Applicant Contact rishi sinha
Correspondent
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis, 
TN 
38116

Correspodent Contact rishi sinha
Regulation Number 888.3353
Classification Product Code
MEH  
Date Received 04/21/2008
Decision Date 07/31/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls