ONCOLOGY SALVAGE SYSTEM


definition

Device Classification Name

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

510(k) Number K002757
Device Name ONCOLOGY SALVAGE SYSTEM
Original Applicant
BIOMET, INC.
airport industrial park,
p.o.box 587
warsaw, 
IN 
46581 -0587

Original Contact tina lakin
Regulation Number 888.3350
Classification Product Code
JDI  
Subsequent Product Code
KRO  
Date Received 09/05/2000
Decision Date 11/24/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls