SMITH & NEPHEW RJ CONSTRAINED LINERS


Device Classification Name

prosthesis, hip, constrained, cemented or uncemented, metal/polymer

510(k) Number K111635
Device Name SMITH & NEPHEW RJ CONSTRAINED LINERS
Applicant
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis, 
TN 
38116

Applicant Contact megan bevill
Correspondent
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis, 
TN 
38116

Correspodent Contact megan bevill
Regulation Number 888.3310
Classification Product Code
KWZ  
Date Received 06/13/2011
Decision Date 09/09/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No