FENNING HIP STEM


definition

Device Classification Name

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

510(k) Number K002441
Device Name FENNING HIP STEM
Original Applicant
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw, 
IN 
46581 -0988

Original Contact arlene c saull
Regulation Number 888.3353
Classification Product Code
LZO  
Subsequent Product Code
JDI  
Date Received 08/09/2000
Decision Date 09/01/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

Type Traditional
Reviewed by Third Party No

Combination Product

No