SMITH & NEPHEW REDAPT REVISION FEMORAL SYSTEM


Device Classification Name

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

510(k) Number K121627
Device Name SMITH & NEPHEW REDAPT REVISION FEMORAL SYSTEM
Applicant
SMITH & NEPHEW, INC.
7135 goodlett farms parkway
cordova, 
TN 
38016

Applicant Contact natalie p williams
Correspondent
SMITH & NEPHEW, INC.
7135 goodlett farms parkway
cordova, 
TN 
38016

Correspodent Contact natalie p williams
Regulation Number 888.3353
Classification Product Code
MEH  
Subsequent Product Code
LZO  
Date Received 06/04/2012
Decision Date 10/15/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No