KEYSTONE HIP


Device Classification Name

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

510(k) Number K000521
Device Name KEYSTONE HIP
Original Applicant
ENCORE ORTHOPEDICS, INC.
9800 metric blvd.
austin, 
TX 
78758

Original Contact debbie de los santos
Regulation Number 888.3358
Classification Product Code
LPH  
Date Received 02/16/2000
Decision Date 05/10/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

Type Traditional
Reviewed by Third Party No

Combination Product

No