SMITH & NEPHEW FEMORAL HEADS


Device Classification Name

prosthesis, hip, semi-constrained, metal/polymer, cemented

510(k) Number K024340
Device Name SMITH & NEPHEW FEMORAL HEADS
Original Applicant
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis, 
TN 
38116

Original Contact kim p kelly
Regulation Number 888.3350
Classification Product Code
JDI  
Subsequent Product Codes
LPH   LZO  
Date Received 12/27/2002
Decision Date 02/26/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No