DEPUY FEMORAL HEADS


Device Classification Name

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

510(k) Number K011533
Device Name DEPUY FEMORAL HEADS
Original Applicant
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw, 
IN 
46581 -0988

Original Contact lynnette whitaker
Regulation Number 888.3353
Classification Product Code
LZO  
Date Received 05/18/2001
Decision Date 01/28/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No