TITAN POROCOAT HIP PROSTHESIS


definition

Device Classification Name

prosthesis, hip, semi-constrained, metal/polymer, porous uncemented

510(k) Number K001991
Device Name TITAN POROCOAT HIP PROSTHESIS
Original Applicant
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw, 
IN 
46581 -0988

Original Contact marcia j arentz
Regulation Number 888.3358
Classification Product Code
LPH  
Date Received 06/29/2000
Decision Date 08/25/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

Type Traditional
Reviewed by Third Party No

Combination Product

No