SMITH & NEPHEW R3 CONSTRAINED LINERS


Device Classification Name

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

510(k) Number K122139
Device Name SMITH & NEPHEW R3 CONSTRAINED LINERS
Applicant
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis, 
TN 
38116

Applicant Contact martin ostmann
Correspondent
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis, 
TN 
38116

Correspodent Contact martin ostmann
Regulation Number 888.3310
Classification Product Code
KWZ  
Date Received 07/19/2012
Decision Date 10/16/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No