OSS LES PROXIMAL FEMORAL COMPONENT


Device Classification Name

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

510(k) Number K021380
Device Name OSS LES PROXIMAL FEMORAL COMPONENT
Original Applicant
BIOMET, INC.
56 bell dr.
po box 587
warsaw, 
IN 
46581 -0587

Original Contact patricia sandborn beres
Regulation Number 888.3350
Classification Product Code
JDI  
Subsequent Product Code
LPH  
Date Received 05/01/2002
Decision Date 05/28/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No