TOTAL HIP FEMORAL HEAD – 12/14 TAPER


Device Classification Name

prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

510(k) Number K021673
Device Name TOTAL HIP FEMORAL HEAD – 12/14 TAPER
Original Applicant
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis, 
TN 
38116

Original Contact kim kelly
Regulation Number 888.3353
Classification Product Code
LZO  
Date Received 05/21/2002
Decision Date 06/11/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No